Published Ongoing Trials ESC Lisbon 2012

OAID 2

Subject area/topic: Ongoing Trial

THE STANDFIRM TRIAL: A DOUBLE-BLIND, CLUSTER RANDOMISED-CONTROLLED TRIAL OF LONG-TERM RISK FACTOR MANAGEMENT IN SURVIVORS OF STROKE.

Background: Comprehensive, community-based preventative care may improve risk factor management of patients with stroke or transient ischaemic attack (TIA). Uptake in general practice is limited. In this randomized controlled trial (RCT) we aim to determine the effectiveness of an individualised management program (IMP) in reducing overall ‘stroke risk’ for patients discharged from hospital after stroke or TIA when compared to patients that receive usual care (UC). Methods: Multicentre cluster RCT, with clusters by general practice. Participants are randomised to receive IMP or UC after hospital discharge. The general practice they attend is marked as an intervention or UC accordingly. All subsequent participants attending those practices are automatically assigned as intervention or UC. Outcome assessors are blinded to patient randomisation. The IMP group receive specialist advice on their risk factors utilising a standardised, evidence-based template to communicate ‘ideal’ management with their general practitioners. The IMP group also receive additional education and support about risk factor management. IMPs are reviewed and modified if appropriate at 3, 6, 12 and 18 months after stroke. Primary Outcome: stroke risk management will be evaluated using changes in the Framingham cardiovascular risk score. Analysis will be ‘intention-to-treat’ using analysis of covariance (ANCOVA) or generalised linear model to adjust for baseline risk score and other relevant confounding factors. Results: Since January 2010 we have recruited 184 patients to this trial, 10 of whom have dropped out. The mean age of participants at stroke onset is 67.98 years and 67% are male. Thirty-two adverse events have been reported during follow-up. Conclusion: Recruitment is on track to be completed by June 2013. If effective this intervention will provide a readily applicable program for primary care clinicians to more effectively manage their patients with stroke.

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Presenting Author
A.G.  Thrift  
Department of Medicine, Southern Clinical School, Monash University 
Clayton  
AUSTRALIA

Trialist: for the STANDFIRM Investigators

Co- Authors 2-15:
 V.K.  Srikanth
Department of Medicine, Southern Clinical School, Monash University   Clayton   AUSTRALIA

M.R.  Nelson
Menzies Research Institute, University of Tasmania   Hobart   AUSTRALIA

J. Kim
Department of Medicine, Southern Clinical School, Monash University   Clayton   AUSTRALIA

 S.M.  Fitzgerald
Department Epidemiology & Preventive Medicine, Monash University   Melbourne   AUSTRALIA

 R.P. Gerraty
 Department of Medicine, Epworth Healthcare, Monash University   Richmond    AUSTRALIA

C.F.  Bladin
Department of Neurosciences, Box Hill Hospital, Monash University   Box Hill   AUSTRALIA

T.G.  Phan
Department of Medicine, Southern Clinical School, Monash University  Clayton   AUSTRALIA

 C.I.  Johnston
Baker IDI Heart & Diabetes Institute   Melbourne   AUSTRALIA

 J.  Bernhardt
Florey Neurosciences Institutes   Heidelberg   AUSTRALIA

L. Churilov
Florey Neurosciences Institutes    Heidelberg   AUSTRALIA

 R.A.L. Macdonell
Neurology Department, Austin Health   Heidelberg   AUSTRALIA

 D.A. Cadilhac
 Department of Medicine, Southern Clinical School, Monash University    Clayton   AUSTRALIA

     
        

OAID 3

Subject area/topic: Ongoing Trial

A longitudinal cohort study on quality of life in stroke patients and their partners: Restore4Stroke Cohort

Background Stroke is a major cause of disability in the Western world. The long-term consequences are found in all areas of functioning in terms of the International Classification of Functioning (ICF), and have a negative impact on the quality of life of both the patients and their partners. Aim The aim of Restore4Stroke Cohort is to investigate the changes in quality of life (QoL) of stroke patients and their partners over time, and to determine factors predicting quality of life in several domains, especially personal and environmental factors. Method Restore4Stroke Cohort is a multicentre prospective longitudinal cohort study involving five assessments in two years. The first assessment takes place in the first week post stroke (during hospital stay). The follow-up assessments take place at two months, six months, one year and two years post stroke. A total of 500 patients are being recruited from stroke units in six participation hospitals. If the patient has a partner, he or she is also asked to participate in the study. Outcomes The main outcome is QoL considered from a general health-related QoL (HRQoL) and domain-specific QoL perspective. Factors predicting long term QoL will be determined by taking into account the pre-stroke health situation, stroke-related characteristics, personal factors (e.g. coping and illness cognitions) and environmental factors (e.g. caregiver burden and social support). Discussion This study is expected to provide information about the changes in the QoL of stroke patients and their partners over time. Furthermore, the factors predicting QoL can potentially be used to improve rehabilitation care and develop new interventions for stroke patients and their partners.

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Presenting Author
P.  de Kort  
St. Elisabeth hospital, Department of Neurology 
Tilburg  
THE NETHERLANDS

Trialist: no trialist: cohort study

Co- Authors 2-15:
 M.  v Mierlo
Rehabilitation Center de Hoogstraat   Utrecht   THE NETHERLANDS

C.  v Heugten
School for Mental Health and Neuroscience, Maastricht University   Maastricht   THE NETHERLANDS

M. Post
Rehabilitation Center De Hoogstraat   Utrecht   THE NETHERLANDS

 J.  Visser-Meily
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

OAID 4

Subject area/topic: Ongoing Trial

Pilot Investigation of Stem Cells in Stroke [PISCES]: A Phase One Study of CTX0E03 Human Neural Stem Cells.

Background: CTX0E03 is a conditionally immortalized human neural stem cell line, originally derived from foetal cortical neuro-epithelium that has been manufactured to clinical grade standard fulfilling Good Manufacturing Practice requirements. In animal studies, CTX0E03 implantation has demonstrated in-vivo survival, migration, neuronal proliferation and differentiation resulting in improved functional outcome. The PISCES trial is a “first in man” safety trial. Aim: To investigate the safety profile of intra-cerebral implantation of CTX0E03 (ReNeuron Ltd. UK); a secondary aim is to explore indices of neurological function. Methods: Open label, single site, ascending dose, Phase 1 clinical trial in 12 male patients with stable disability (NIHSS>6, mRS>1) who suffered ischemic MCA territory stroke 6 months to 5 years previously. Four groups of 3 patients each will receive 2, 5, 10 and 20 million cells respectively, implanted in the putamen by stereotaxic injection. Follow up will be for 2 years with clinical (NIHSS, mRS, BI, MMSE, EuroQoL) and radiological data (MRI, MRS, fMRI, DTI) collected. The primary endpoint is safety, including adverse events, neurological deterioration, or mortality. Secondary endpoints are the assessments of functional outcome at 24 months. Results/ Status: As of 30 Jan 2012, five subjects have been implanted, with no cell-related adverse events being identified in follow-up between 2 and 14 months in duration. At enrollment, the mean age of five subjects is 74.6years (range 68-83yrs) with median NIHSS of 8 and mean time from stroke onset is 30.2months. Conclusion: The PISCES trial will test the safety, feasibility and potential efficacy biomarkers of the CTX0E03 neural stem cells in stroke patients. Register: ClinicalTrials.gov NCT01151124 Contacts:Keith.Muir@glasgow.ac.uk; Dheeraj.Kalladka@glasgow.ac.uk

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Presenting Author
D.  Kalladka  
University of Glasgow 
Glasgow  
UNITED KINGDOM

Trialist: Stroke Research Group, Southern General Hospital

Co- Authors 2-15:
 K.W.  Muir
University of Glasgow   Glasgow   UNITED KINGDOM

OAID 6

Subject area/topic: Ongoing Trial

Cognitive Training & Occupational Recreational Therapy on Elderly Japanese In Osaka: major outcome (ADAS) from Prospective, Randomized, Open, Blind-Endpoint Trial

【Background】 In Japan, cognitive training (CT) become popular. Adult day-care facilities where occupational / recreational therapy (ORT) are commonly performed also have become prevalent instantly after the long term care insurance started. Though many different kinds of non-pharmacological programs are running, the evidence of the effectiveness is still limited. 【objectives】 To examine the effects of non-pharmacological therapies (CT, ORT) in day-care facilities. To examine what kind of participants responds to these interventions. 【Methods】 A volunteer sample of more than 100 persons was recruited from six adult day-care facilities in Osaka. Participants in each institute were randomized into two groups. One group participated in CT　(simple arithmetic calculation including simulation of daily living shopping and reading Japanese elementary school textbook aloud), the other group participated in ORT (painting and handicraft). The same number of therapist per participants was allocated in both therapies. They attended twice a week for 30 minutes, and continued for six months. Main outcome focused on change of cognitive function using ADAS which was assessed by blinded clinical psychotherapists. 【Results】 ①As a whole, adjusted mean of ADAS-cog. score in CT group improved significantly compared to baseline and ORT group. ②In participants with history of stroke, adjusted mean of ADAS-cog in ORT group improved significantly compared to baseline and CT group. In participants without history of stroke, adjusted mean of ADAS-cog in CT group improved significantly compared to baseline and ORT group. 【Conclusions】 Single-blind multi-center RCT were performed. (n=114, 30min/session, twice a week, 6 months) Cognitive training (CT) and occupational / recreational therapy (ORT) were well tolerable for the elderly at adult day-care facilities. As a whole, ADAS-cog score in CT group improved significantly compared to baseline and ORT group. Responders to ORT are with history of stroke participants, responders to CT are no history of stroke participants. We will present further analyses at the conference.

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Presenting Author
N.  Hayashi  
Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine 
Suita  
JAPAN

Trialist: Elderly Japanese in adult day-care facilities

Co- Authors 2-15:
     
       

OAID 7

Subject area/topic: Ongoing Trial

Paracetamol (Acetaminophen) in Stroke 2 (PAIS 2): a randomized, placebo-controlled clinical trial of high-dose paracetamol in patients with acute stroke and a body temperature of 36.5°C or above

Background An increase in body temperature in the first hours after stroke is strongly associated with unfavorable functional outcome. Whether prevention of this increase improves functional outcome is unclear. In the Paracetamol (Acetaminophen) in Stroke (PAIS 1) trial, a randomized, double-blind, placebo-controlled clinical trial of 1400 patients with acute stroke, early treatment with paracetamol (6 g daily for 3 days) improved functional outcome at 3 months in patients with a baseline body temperature of 36.5 degrees Celsius or above (odds ratio 1.31; 95% confidence interval: 1.01 to 1.68). As these results are based on a post-hoc subgroup analysis, this observation needs confirmation in an independent study. Objective To assess the effect of high-dose paracetamol on functional outcome in patients with acute stroke and a body temperature of 36.5 degrees Celsius or above. Methods PAIS 2 is a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aim to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients will be treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome is improvement on the modified Rankin Scale at 3 months, assessed with multivariable ordinal logistic regression. PAIS 2 has been registered as NTR2365 in the Netherlands Trial Register. Study progress As of January 2012, 8 centers in the Netherlands participate in PAIS 2. Patient recruitment has started in September 2011. Discussion When early treatment with high-dose paracetamol will be proven effective, a simple, safe and extremely inexpensive therapy will be available for many patients with acute stroke worldwide.

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Presenting Author
I.R.  de Ridder  
Department of neurology, Erasmus MC University Medical Center 
Rotterdam  
THE NETHERLANDS

Trialist: for the PAIS 2 investigators

Co- Authors 2-15:
 H.M.  den Hertog
Department of neurology, Erasmus MC University Medical Center   Rotterdam   THE NETHERLANDS

H.B.  van der Worp
Department of Neurology, Rudolf Magnus Institute for Neuroscience, University Medical Center Utrecht   Utrecht   THE NETHERLANDS

H.M.A. van Gemert
Department of neurology, Meander Medical Center   Amersfoort   THE NETHERLANDS

 A.H.C.M.L.  Schreuder
Department of neurology, Atrium Medical Center   Heerlen   THE NETHERLANDS

 A. Ruitenberg
 Department of neurology, Admiraal de Ruyter Hospital   Goes    THE NETHERLANDS

E.  Maasland
Department of neurology, Van Weel-Bethesda Hospital   Dirksland   THE NETHERLANDS

R.  Saxena
Department of neurology, Maasstad Hospital  Rotterdam   THE NETHERLANDS

 P.J.  Koudstaal
Department of neurology, Erasmus MC University Medical Center   Rotterdam   THE NETHERLANDS

 L.J.  Kappelle
Department of Neurology, Rudolf Magnus Institute for Neuroscience, University Medical Center Utrecht   Utrecht   THE NETHERLANDS

A. Algra
Dept of Neurology, Rudolf Magnus Institute for Neuroscience and Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht    Utrecht   THE NETHERLANDS

 D.W.J. Dippel
Department of neurology, Erasmus MC University Medical Center   Rotterdam   THE NETHERLANDS

OAID 8

Subject area/topic: Ongoing Trial

Design of multi-center, randomized, trial: Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE), comparing inhibitory effect of cilostazol versus other anti-platelet for the in-stent restenosis after carotid artery stenting

Background and Purpose: Carotid artery stenting (CAS) is catheter intervention to treat carotid disease, but in-stent restenosis (ISR) is still factor for recurrent stroke. The present study was conducted to evaluate the inhibitory effect of cilostazol on ISR, compared to that of other antiplatelet, in patients scheduled to undergo CAS. Methods: The Carotid Artery Stenting with Cilostazol Addition for Restenosis (CAS-CARE) trial is a multi- center, prospective, randomized, open-label, blind-endpoint trial, designed to compare the efficacy of cilostazol versus other anti-platelet on ISR after CAS. Main inclusion criteria are patients with diagnosis of carotid artery stenosis, scheduled for CAS within 30 days of enrolment, and aged 45 - 80. Diagnosis of carotid artery stenosis is based on angiography (NASCET stenosis ratio > 50% for symptomatic lesion or > 80% for asymptomatic lesion), or carotid ultrasound (peak systolic velocity > 130cm/sec for symptomatic lesion or > 230cm/sec for asymptomatic lesion). 900 patients will be randomized into 2 groups: the first group will receive cilostazol from at least 3 days before CAS and continue for 2 years. The second group will never receive cilostazol during the same period. Use of other antiplatelet agents and concomitant drugs is unrestricted in each group. The allocation adjusting factors are presence or absence of symptoms, presence or absence of diabetes mellitus, type of stent scheduled to be used (open cell vs. closed cell), and test center. Follow-up carotid ultrasound will be examined at 6, 12 and 24 months after CAS, and carotid restenosis ≥50% is diagnosed using velocity criteria. The primary outcome is occurrence of in-stent restenosis within 2 years after CAS and time to occurrence. Secondary outcomes include 1) occurrence of in- stent restenosis, new out-stent stenosis, or re-treatment, 2) occurrence of cardiovascular event or death from any cause, 3) occurrence of a hemorrhagic event, and 4) a composite endpoint of them. Conclusion: CAS-CARE will determine whether cilostazol can prevent restenosis after CAS with an acceptable risk profile.

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Presenting Author
N.  SAKAI  
Kobe City Medical Center General Hospital 
Kobe  
JAPAN

Trialist: CAS-CARE trialist

Co- Authors 2-15:
 H.  YAMAGAMI
Kobe City Medical Center General Hospital   Kobe   JAPAN

K.  MINEMATSU
National Cerebral and Cardiovascular Center   Suita   JAPAN

I NAGATA
Nagasaki University   Nagasaki   JAPAN

 K.  OGASAWARA
Iwate Medical University   Morioka   JAPAN

 M. SASAKI
 Iwate Medical University   Morioka    JAPAN

K.  NAGATSUKA
National Cerebral and Cardiovascular Center   Suita   JAPAN

Y.  MATSUMARU
Toranomon Hospital  Tokyo   JAPAN

 S.  YOSHIMURA
Gifu University   Gifu   JAPAN

OAID 9

Subject area/topic: Ongoing Trial

Cluster randomised trial evaluation of a patient and carer-centred system of longer-term stroke care (LoTS care stroke system of care trial)

Background: Longer-term recovery is poor for many stroke patients, who may become depressed and house-bound while their carers may be stressed and anxious. Despite recognition of the importance of the longer-term consequences of stroke, services addressing these needs remain poorly developed in the UK. The LoTS care stroke system of care trial aims to improve outcomes after stroke by addressing the longer-term needs of patients and carers. Methods: This cluster randomised, controlled trial evaluates the clinical and cost-effectiveness of a system of care for stroke patients and carers living in the community. The system of care was developed through systematic reviews of the quantitative and qualitative stroke literature and interviews with stroke patients and carers. The resulting comprehensive framework represents the range of longer-term problems experienced by stroke patients and carers. It comprises a structured assessment linked to evidenced-based treatment algorithms and reference guides contained in a manual. It is supported by training and is being delivered by health professionals undertaking a community–based liaison or co-ordinating role for stroke patients (‘Stroke Care Co-ordinators’ (SCCs)). SCCs in the control arm are continuing to deliver their usual practice. The primary outcome is patient emotional health measured using the GHQ12 at 6 months post-recruitment with final follow-up at 12 months. The secondary outcomes include patient functional health, psychological and functional outcomes for carers and analysis of cost-effectiveness. Results: The recruitment phase of the trial has been completed with 800 patients recruited from 29 stroke services across the UK. 401 patients were recruited to the intervention arm and 399 to the control arm. 26% of patients also have carers who have been recruited to the trial. 6 month follow up of participants is complete and 12 month follow up is ongoing until May 2012. Results will be published at the end of 2012.

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Presenting Author
K.  Chapman  
Bradford Teaching Hospitals NHS Foundation Trust 
Bradford  
UNITED KINGDOM

Trialist: LoTS care Stroke System of Care trial team

Co- Authors 2-15:
     
       

OAID 11

Subject area/topic: Ongoing Trial

Repetitive transcranial magnetic stimulation as supportive treatment of post-stroke aphasia: an ongoing randomized controlled trial.

Background and purpose Recently case series and small pilot studies suggest that non-invasive repetitive transcranial magnetic stimulation (rTMS) over non-dominant hemisphere might improve the effect of conventional therapy for recovery from post-stroke aphasia. A larger controlled trial to further support safety and efficacy of TMS for aphasia recovery is still missing. Methods In this ongoing randomized, controlled and blinded study, the effect of 1Hz repetitive transcranial magnetic stimulation (rTMS) over the non-dominant Broca´s homologue is being examined. Here we report the results of the first 21 subjects with post-stroke aphasia in the subacute stage. According to their group allocation patients received, additionally to conventional speech and language therapy, 10 sessions of rTMS either over the inferior frontal gyrus of the non dominant-hemisphere (intervention group) or over the vertex (control group). The primary outcome measure is the change in the global score of the Aachen Aphasia Test (AAT) battery, secondary outcome variables are AAT subtests and the extent of interhemispheric activation shift as measured with language activation positron emission tomography (PET). Results At baseline, no group differences were discovered for age, laterality indices or mean AAT scores. There was a significant difference in pre- and post treatment global AAT scores between TMS-treated and sham-treated groups with significantly higher mean scores in the treatment group (TMS-group: 22.8 +/- 12.36, Sham-group 9.4 +/- 12.79, p=0.032). A repeated measures analysis of variance demonstrated a highly significant treatment effect across all subtests (P=0.002), the most significant effect for the subtest picture naming. PET revealed a shift of activated language-related cortex towards the left hemisphere in the intervention group. Conclusions Repetitive TMS might be an effective, safe and feasible complementary therapy for post-stroke aphasia.

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Presenting Author
A.  Thiel  
Department of Neurology & Neurosurgery McGill University  
Montreal  
CANADA

Trialist: 

Co- Authors 2-15:
 C.  Anglade
Department of Neurology & Neurosurgery McGill University    Montreal    CANADA

N.  Weiduschat
Cornell University   New York   USA

J. Kessler
Max Planck Institute for neurological reserach   Cologne   GERMANY

 I.  Rubi-Fessen
ReHa Nova   Cologne   GERMANY

 A. Hartmann
 Reha Nova   Cologne    GERMANY

W.D.  Heiss
Max Planck Institute for neurological reserach   Cologne   GERMANY

OAID 14

Subject area/topic: Ongoing Trial

The Interventional Management of Stroke (IMS) III Trial: An Ongoing Phase III Trial

BACKGROUND AND PURPOSE: IMS I and II pilot trials showed that the combined intravenous (IV) and intra-arterial (IA) approach to recanalization may be more effective than standard IV rt-PA Activase®) alone for moderate-to-large (NIHSSS ≥10 or 8-9 with positive CTA) strokes, and with a similar safety profile. Primary objective of this NIH-funded, Phase III, randomized, multi-center, open-label clinical trial is to determine if a combined IV/IA approach to recanalization is superior to standard IV rt-PA alone when initiated within three hours of acute ischemic stroke onset. METHODS: A projected 900 subjects with moderate-to-large ischemic strokes between ages 18-82 will be enrolled at 50+ centers in the United States, Canada, Australia and Europe. All subjects must have IV treatment initiated within three hours of stroke onset. Subject randomization is a 2:1 ratio with more enrolled in the combined IV/IA group. Both treatment arms will receive full standard dose (0.9 mg/kg, 90 mg max [10% as bolus]) of rt-PA intravenously over one hour. Randomization must occur within 40 minutes of starting the infusion. Combined IV/IA group will be sent immediately for angiography. No IA therapy will be administered if a treatable thrombus is not demonstrated. If an appropriate thrombus is identified, treatment will continue with either the Merci® Retriever, the Penumbra System™, the Solitaire™ FR Revascularization Device, infusion of rt-PA and delivery of low-intensity ultrasound via the EKOS® Catheter (in US only), or infusion of rt-PA via a standard microcatheter. IA treatment must begin within 5 hours and be completed by 7 hours of stroke onset. Primary outcome measure is defined as a modified Rankin Score (mRS) of 0-2 at 3 months. Primary safety measure is mortality at 3 months and symptomatic ICH within the first 36 hours after onset. CONCLUSIONS: The IMS III Trial will develop a network of interventional centers to test the safety, feasibility, and potential efficacy of a combined IV/IA approach to recanalization using intra-arterial infusion of rt-PA and/or FDA-approved catheter devices. As of February 27, 2012, 632 subjects had been randomized.

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Presenting Author
J.P.  Broderick  
University of Cincinnati 
Cincinnati OH  
USA

Trialist: Joseph P. Broderick, MD & Thomas A. Tomsick, MD

Co- Authors 2-15:
 T.A.  Tomsick
University of Cincinnati   Cincinnati OH   USA

OAID 15

Subject area/topic: Ongoing Trial

Stroke in Primary Systemic Vasculitis – DCVAS stroke study

Background: The exact incidence of stroke as a presenting manifestation of systemic vasculitis is unknown. The cumulative incidence of stroke in vasculitis has been reported to be as high as 16%, which might be a direct consequence of vasculitis or secondary to other causes such as accelerated atherosclerosis. Few studies have analysed stroke occurrence or subtype in primary vasculitis. Stroke in primary vasculitis may need specific therapeutic strategies and may be associated with additional burden of the disease. Aim: The “Stroke in Primary Systemic Vasculitis Sub-study” aims to describe stroke subtypes associated with each form of systemic vasculitis, including primary cerebral vasculitis and describe stroke associated disability and recurrence within a 6 month period. Methods: The DCVAS study is a multicenter, prospective study aiming to define new classification and diagnostic criteria for primary vasculitis and to validate these criteria. At the end of the study, well-characterized groups of patients with different types of primary vasculitis (2000) will be obtained as well as control patients (1500) with diagnoses that mimic primary vasculitis. Included patients will be adults ≥18 years with a new presentation/clinical suspicion of a primary vasculitis. A questionnaire regarding stroke diagnosis, etiological classification and disability will be applied at baseline in all patients. Final vasculitis diagnosis, stroke recurrence and disability will be evaluated at six months. We will evaluate the difference between patients with primary cerebral vasculitis, those with another form of systemic vasculitis and those with disease which mimics vasculitis. Expected results: We expect to at least include 70 patients with vasculitis and TIA/stroke and 120 patients with vasculitis mimics and TIA / stroke. Conclusion: This study represents an unique opportunity to describe the clinical details of incident cerebrovascular disease in several forms of systemic vasculitis over the first 6 months

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Presenting Author
R.  Geraldes  
Stroke Unit, Department of Neurosciences, Santa Maria Hospital 
Lisbon  
PORTUGAL

Trialist: DCVAS

Co- Authors 2-15:
 A.C.  Fonseca
Stroke Unit, Department of Neurosciences, Santa Maria Hospital   Lisbon   PORTUGAL

P.C.  Canhão
Stroke Unit, Department of Neurosciences, Santa Maria Hospital   Lisbon   PORTUGAL

TP Melo
Stroke Unit, Department of Neurosciences, Santa Maria Hospital   Lisbon   PORTUGAL

 J.M.  Ferro
Stroke Unit, Department of Neurosciences, Santa Maria Hospital   Lisbon   PORTUGAL

 R. Watts
 Rheumatology Department Ipswich Hospital and University of East Anglia   Norwich    UNITED KINGDOM

P.  Merkel
Division of Rheumatology, University of Pennsylvania   Philadelphia   USA

P.  Grayson
Section of Rheumatology & the Clinical Epidemiology Unit, Boston University School of Medicine  Boston   USA

 J.  Robson
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford   Oxford   UNITED KINGDOM

 A.  Craven
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford   Oxford   UNITED KINGDOM

R. Suppiah
Auckland District Health Board    Auckland    NEW ZEALAND

 R. Luqmani
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford   Oxford   UNITED KINGDOM

OAID 16

Subject area/topic: Ongoing Trial

COOLIST: COOLing for Ischaemic Stroke Trial. A phase II randomised clinical trial.

Background: Cooling to 32 - 34°C improves outcome in patients with post-anoxic encephalopathy after cardiac arrest. Animal studies strongly suggest that cooling also improves outcome after ischaemic stroke. In these studies, cooling was efficacious at temperatures of 35°C or below, with lower temperatures associated with a greater benefit. In clinical practice however, each ˚C decrease in temperature may be tolerated less well by awake patients on a stroke unit. In contrast to endovascular cooling, surface cooling can probably be combined with concurrent thrombolysis. The feasibility of surface cooling to temperatures of 35°C or below in patients with acute ischaemic stroke has not been evaluated systematically in clinical studies. Aim: To compare the feasibility and safety of surface cooling to 34, 34.5, and 35˚C, started within 4.5 hours after the onset of acute ischaemic stroke and maintained for 24 hours, in awake patients on a stroke unit. Methods: This is a randomised, open, multi-centre, phase II clinical trial with masked outcome assessment, comparing three different surface cooling strategies with standard treatment in 48 awake adult patients with acute ischaemic stroke and a score on the NIH Stroke Scale ≥ 6, admitted to a stroke unit. Intravenous or intra-arterial thrombolysis or thrombectomy are not exclusion criteria. Patients will be randomised to conventional treatment (n = 12) or to surface cooling to 34, 34.5, or 35°C maintained for 24 hours (n = 12 in each group). In all patients randomised to hypothermia, cooling will be started within 4.5 hours after the onset of symptoms by means of intravenous infusion of 20 ml/kg cooled normal saline (4°C) over 30 to 60 minutes, followed by surface cooling. Shivering and discomfort will be prevented and treated with intravenous pethidine and with oral buspirone. The primary outcome measure is feasibility, defined as the number of patients that has successfully completed the treatment strategy they had been assigned to. Secondary outcome measures include the time to target temperature, stability at target, complications, and the score on the modified Rankin Scale at three months.

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Presenting Author
M.  Geurts  
UMC Utrecht 
Utrecht  
THE NETHERLANDS

Trialist: NL32092.041.10

Co- Authors 2-15:
 D.W.J.  Dippel
Erasmus MC   Rotterdam   THE NETHERLANDS

G.J.  Luijckx
UMC Groningen   Groningen   THE NETHERLANDS

A. Algra
Julius Center   Utrecht   THE NETHERLANDS

 L.J.  Kappelle
UMC Utrecht   Utrecht   THE NETHERLANDS

 H.B. van der Worp
 UMC Utrecht   Utrecht    THE NETHERLANDS

OAID 18

Subject area/topic: Ongoing Trial

CAPIAS-Carotid Plaque Imaging in Acute Stroke

Introduction: In up to 40% of ischemic stroke patients, no definite cause can be established. Current stroke classification schemes consider atherosclerotic lesions of the carotid bifurcation only as causative, if they are associated with substantial luminal narrowing. It has been shown that the degree of luminal stenosis alone is insufficient to determine a plaque`s vulnerability. Our pilot study suggested that arterio-arterial embolism from non-stenosing AHA-LT6 carotid plaques may play a role in patients previously diagnosed with a stroke of unknown etiology. The hypotheses behind this study are that a substantial proportion of strokes in the anterior circulation are caused by AHA-LT6 plaques, that these patients are at high risk of developing a recurrent stroke and that AHA-LT6 plaques are associated with specific infarct patterns. Methods: In a multicenter approach 300 patients (age > 49 years) with a DWI-positive lesion in the territory of a single ICA and carotid artery plaques ipsi- or contralateral will be enrolled. Patients undergo clinical, technical and laboratory investigations. For plaque characterization all patients receive black-blood carotid MRI at 3.0-Tesla within 7 days of the event. In addition contrast enhanced carotid ultrasound is performed. Follow-up will take place 3 and 12 months after the initial event. Results: The interim results of the first 50 patients were evaluated. According to the TOAST classification, 27 strokes were cryptogenic, 11 cardioembolic, 8 micro- and 4 macroangiopathic strokes. Prevalence of complicated AHA-LT6 differed across the groups and was 37% in TOAST 1 and 10,5% in TOAST 2-4. Considerations: Data on the frequency and characteristics of AHA-LT6 plaques in patients with acute ischemic stroke or TIA of unknown etiology will provide valuable insights into stroke mechanisms. This study may have important implications for diagnostic decision making and provide the basis for the planning of targeted interventional studies.

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Presenting Author
A.  Karpinska  
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University 
Munich  
GERMANY

Trialist: www.clinicaltrials.gov/NCT01284933

Co- Authors 2-15:
 T.  Saam
Institute for Clinical Radiology, Ludwig-Maximilians-University   Munich   GERMANY

F.  Schwarz
Institute for Clinical Radiology, Ludwig-Maximilians-University   Munich   GERMANY

D.A. Clevert
Institute for Clinical Radiology, Ludwig-Maximilians-University   Munich   GERMANY

 J.  Grimm
Institute for Clinical Radiology, Ludwig-Maximilians-University   Munich   GERMANY

 C. Cyran
 Institute for Clinical Radiology, Ludwig-Maximilians-University   Munich    GERMANY

T.  Freilinger
Department of Neurology, Ludwig-Maximilians-University   Munich   GERMANY

C.  Schäffer
Department of Neurology, Technical University  Munich   GERMANY

 C.  Sailer
Department of Neurology, Technical University   Munich   GERMANY

 T.  Boeckh-Behrens
Department of Radiology, Technical University   Munich   GERMANY

C. Opherk
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

 H. Poppert
Department of Neurology, Technical University   Munich   GERMANY

 M.F. Reiser
 Institute for Clinical Radiology, Ludwig-Maximilians-University    Munich   GERMANY

 K.  Nikolaou
Institute for Clinical Radiology, Ludwig-Maximilians-University    Munich   GERMANY

M. Dichgans
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

OAID 21

Subject area/topic: Ongoing Trial

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: Design, Methods, and Rationale

The December 2003 report from a National Institute of Neurological Disorders and Stroke (NINDS) Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) recommended clinical trials for evaluation of blood pressure management in acute ICH as a leading priority. We have initiated a multi-center, randomized Phase III trial, the ATACH II Trial, to definitively determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine initiated within 3hours of onset of ICH and continued for the next 24 hours in subjects with spontaneous supratentorial ICH. The primary hypothesis of this large (N=1,280), streamlined, focused trial is that SBP reduction to ≤140mm Hg reduces the likelihood of death or disability at 3months after ICH, defined by modified Rankin scale (mRS) score of 4-6, by at least absolute 10% compared to standard SBP reduction to ≤180mm Hg. The ATACH II Trial is a natural extension of numerous case series, the subsequent ATACH I pilot trial, and a preliminary randomized controlled trial in this patient population funded by the Australian National Health and Medical Research Council. Both trials recently confirmed the safety and tolerability of both the regimen and goals of antihypertensive treatment in acutely hypertensive patients with ICH, as proposed in the present trial. The underlying mechanism for this expected beneficial effect of intensive treatment is presumably mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 73% of patients with acute ICH. The ATACH II trial will have important public health implications by providing evidence of, regarding the efficacy and safety of acute antihypertensive treatment in subjects with ICH. This treatment represents a strategy that can be made widely available without the need for specialized equipment and personnel, and therefore, can make a major impact upon clinical practice for treating patients with ICH.

Graphic/Table:  
 

Presenting Author
A.I.  Qureshi  
University of Minnesota 
Minneapolis  
USA

Trialist: ATACH-II

Co- Authors 2-15:
     
       

OAID 22

Subject area/topic: Ongoing Trial

Prognostic significance of hemodynamic and hemostatic factors in the course of different manifestations of cerebral small vessel disease - study rational and protocol.

Introduction Cerebral small vessel disease (CSVD) is one of the most important and common vascular diseases of the brain. It is an important cause of ischemic and hemorrhagic strokes, dementia and vascular parkinsonism. Although main clinical and radiological signs of CSVD are well established its prognostic factors and course have not been well studied so far. The aim of the study is to evaluate hemodynamic and hemostatic factors and to assess clinical and radiological course of different manifestations of CSVD in long term observation. Method A prospective, observational, with 24-month follow-up study in 150 CSVD patients (50 with lacunar stroke, 50 with vascular dementia, 25 with vascular parkinsonism, 25 with deep intracerebral hemorrhage) and 50 healthy subjects from control group has been planned. The clinical and radiological course will be evaluated basing on a detailed neurological, neuropsychological and MRI examinations. Hemodynamic (cerebral vasoreactivity, 24h blood pressure control, MRI PWI/DWI) and hemostatic (markers of endothelial and platelet dysfunction, brachial artery flow-mediated dilatation test) factors will be determined. Discussion The study has the potential to further unravel the predictors and course of different manifestations of CSVD. The scheduled trial will better define the prognosis and prognostic factors of various clinical manifestations of CSVD. These data may be helpful in considering the development of preventive and therapeutic strategies in CSVD especially in the context of individualization of the treatment.

Graphic/Table:  
 

Presenting Author
J.  Staszewski  
Military Institute of Medicine 
Warsaw  
POLAND

Trialist: 003

Co- Authors 2-15:
 R.  Piusinska-Macoch
Military Institute of Medicine   Warsaw   POLAND

E.  Skrobowska
Military Institute of Medicine   Warsaw   POLAND

OAID 23

Subject area/topic: Ongoing Trial

Trial of WiiTM in STroke- TWIST Does the use of Nintendo WiiTM Sports improve dominant arm function and is it acceptable to patients after stroke?

Background Many stroke patients experience altered arm function requiring rehabilitation which is expensive, repetitive and doesn’t always translate into ‘real life’. Nintendo Wii SportsTM offers task specific training that is repetitive and motivating. We investigate whether the WiiTM, when played at home, improves arm function and is acceptable for patients after stroke. Methods This is a pragmatic multicentre randomised controlled trial with blinded outcome assessment, qualitative study and health economics analysis. We investigate whether use of Wii SportsTM improves dominant arm function in people with dominant arm weakness following stroke, in comparison to home exercises. Primary outcome is change in dominant arm function at 6 weeks follow-up in intervention and control groups using the Action Research Arm Test (ARAT). Secondary outcomes include occupation performance, quality of life, cost effectiveness analysis; factors influence its use for patients and carers. We aim to recruit 240 participants in the South West of the UK. Following baseline assessments participants will be randomised into one of 2 groups, all participants exercising at home for up to 45 minutes daily for 6 weeks. The intervention group will play Wii SportsTM and the control group will have tailored arm exercises. Participants will be followed up at 6 weeks and 6 months. Outcome measures include the ARAT, Canadian Outcome Performance Measure, Stroke Impact Scale, EQ-5D. Semi-structured interviews will be held with participants and cost utility analysis performed. Results Ethical approval has been obtained from NRES Committee South Central Portsmouth. Participant recruitment started in January 2012. Conclusions Study completion anticipated October 2013.

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Presenting Author
K.  Adie  
Royal Cornwall Hospital Trust 
Truro  
UNITED KINGDOM

Trialist:  

Co- Authors 2-15:
 C.  Schofield
Royal Cornwall Hospital Trust   Truro   UNITED KINGDOM

M.  Berrow
Clinical Trials Unit   Plymouth   UNITED KINGDOM

J. Wingham
Royal Cornwall Hospital   Truro   UNITED KINGDOM

 J.  Freeman
Independent Statistician   Cadgwith   UNITED KINGDOM

 J. Humfryes
 Patient representative   Mullion    UNITED KINGDOM

C.  Pritchard
Royal Cornwall Hospital Trust   Truro   UNITED KINGDOM

OAID 24

Subject area/topic: Ongoing Trial

Comparison of decompressive hemicraniectomy and conservative craniotomy in supratentorial spontaneous intracerebral hemorrhage

Objective Decompressive craniectomy (DC) is used regularly in large amount of supratentorial spontaneous ICH. However, consensus on DC surgery for ICH has not been reached. We conducted a retrospective study to assess the effect of DC on outcome of patients with spontaneous basal ganglia hemorrhage Methods WE evaluated the clinical, radiologic finding and outcome of large amount of supratentorial spontaneous ICH who performed hematoma evacuation. Supratentorial ICHs that exhibited a hematoma volume of over 50mL according to the xyz/2 method were included in this study. We compared a hematoma removal plus DC group and a hematoma removal group (HR) with regard to GCS, preoperative hematoma volume, shift from the midline, time from ictus to surgery, post-surgical hematoma volume, brain swelling, hospitalization period and mRS after 3 months. Statistical analysis was done using the t-test or x2test, and the odds ratio was calculated. Results 56 patients participated in this study. Mean age of DC and HR group was 24 and 32 years, respectively. GCS, preoperative hematoma volume, midline shifting, time from the ictus to surgery and postoperative hematoma volume were similar between both groups. Hospitalization periods increased in the DC group. The mRS after 3 months was similar for both groups. The factor relevant for mRS were age, postoperative hematoma volume, and GCS at 24 h after surgery. Conlucsion DC is not necessary for spontaneous supratentorial ICH if the hematoma can be removed properly.

Graphic/Table:  
 

Presenting Author
S.K.  Park  
Incheon St.Mary's Hospital 
Incheon  
SOUTH KOREA

Trialist:  

Co- Authors 2-15:
 Y.M  Han
Incheon St.Mary's Hospital   Incheon   SOUTH KOREA

K.S  Jang
Incheon St.Mary's Hospital   Incheon   SOUTH KOREA

D.K Jang
Incheon St.Mary's Hospital   Incheon   SOUTH KOREA

 S.H  Lim
Incheon St.Mary's Hospital   Incheon   SOUTH KOREA

OAID 25

Subject area/topic: Ongoing Trial

VAST: Vertebral Artery Stenting Trial

Background: Of all transient ischaemic attacks (TIA’s) and ischaemic strokes, 20 to 30% involves tissue supplied by the vertebrobasilar circulation. In about a quarter of the patients a symptomatic, atherosclerotic stenosis >/= 50% of the vertebral artery is found. Patients with a vertebrobasilar stenosis have the highest risk of recurrent vertebrobasilar stroke. For these patients treatment of vertebral artery stenosis by percutaneous transluminal angioplasty has been introduced as an attractive treatment option. The safety and benefit of stenting as compared with best medical therapy alone remains to be elucidated in a randomised clinical trial. Objectives: The primary aim of the Vertebral Artery Stenting Trial (VAST; ISRCTN29597900) is to assess whether stenting for symptomatic vertebral artery stenosis >/= 50% is both feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar arteries in patients with symptomatic vertebral artery stenosis >/= 50% on best medical therapy with or without stenting. Design: This randomised open clinical trial, compares best medical treatment with or without vertebral artery stenting in patients with recently symptomatic vertebral artery stenosis >/= 50%. The trial will include a total of 180 patients with TIA or non-disabling ischaemic stroke that may be attributed to vertebral artery stenosis of at least 50%. The primary outcome is any stroke, vascular death, or non-fatal myocardial infarction within 30 days after start of treatment. Secondary outcome measures include any stroke or vascular death during follow-up and the degree of (re)stenosis after one year. As of March 2012, a total of 87 patients have been included. Funding: Netherlands Heart Foundation, grant number 2007B045.

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Presenting Author
A.  Compter  
University Medical Center Utrecht 
Utrecht  
THE NETHERLANDS

Trialist: The VAST investigators

Co- Authors 2-15:
     
       

OAID 26

Subject area/topic: Ongoing Trial

A Multicentre randomised trial to establish the effect (s) of routine administration of Fluoxetine in patients with a recent stroke (Fluoxetine Or Control Under Supervision, FOCUS)

Background. Several small trials have demonstrated that fluoxetine given within the first 3 months of stroke, even in patients who are not depressed, improves overall recovery and reduces disability as well as reducing the risk of post-stroke depression. These promising results need to be confirmed by larger trials. Aims. We aim to determine whether fluoxetine 20mg daily for 6 months, started at 2-15 days after stroke onset in patients with persisting neurological deficits, reduces dependency at 6 months and whether any benefits persist to 12 months. Methods. This multicentre UK, randomised placebo-controlled trial aims to recruit 3000 patients. Eligible patients will be randomised by a central web-based system, thus ensuring allocation concealment. Data on our primary outcome (modified Rankin scale, mRs) and our secondary outcomes (survival, health related quality of life, mood, fatigue, overall level of recovery (Stroke Impact Scale), new clinical diagnosis of depression and resource use) will be collected by local follow-up at hospital discharge (for inpatients) and central follow-up at one month (for outpatients) and at 6 and 12 months via postal, web or telephone questionnaires to patients and general practitioners. Based on a sample size for a binary outcome, a trial of 3000 (1500 per group) will provide greater than 90% power (alpha=0.05) to detect a 5.5% absolute increase in proportion of patients with a mRs of 0-2 (i.e. independent) (odds ratio=1.30). Using an ordinal sample size method, we will detect a common odds ratio of 1.23. We are harmonising assessments with the Australian AFFINITY (Assessment of fluoxetine in stroke recovery) and Swedish EFFECTS (Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke) trial investigators to allow future joint analyses. Potential impact. FOCUS will tell us whether this simple, inexpensive treatment, with very few serious side effects improves overall recovery in a broad range of stroke patients.

Graphic/Table:  
 

Presenting Author
G.E.  Mead  
University of Edinburgh 
Edinburgh  
UNITED KINGDOM

Trialist: for FOCUS trialists

Co- Authors 2-15:
 M.S.  Dennis
University of Edinburgh   Edinburgh   UNITED KINGDOM

K.  Innes
University of Edinburgh   Edinburgh   UNITED KINGDOM

M. MacLeod
University of Edinburgh   Edinburgh   UNITED KINGDOM

 P.A.G.  Sandercock
University of Edinburgh   Edinburgh   UNITED KINGDOM

 A. House
 University of Leeds   Leeds    UNITED KINGDOM

F.  Sullivan
University of Dundee   Dundee   UNITED KINGDOM

M.  Hackett
George Institute for Global Health  Sydney   AUSTRALIA

 C.  Anderson
George Institute for Global Health   Sydney   AUSTRALIA

 G.  Hankey
The University of Western Australia   Perth   AUSTRALIA

S. Lewis
University of Edinburgh    Edinburgh   UNITED KINGDOM

 C. Graham
University of Edinburgh   Edinburgh   UNITED KINGDOM

 J. Forbes
 University of Edinburgh    Edinburgh   UNITED KINGDOM

 C.  Williams
University of Edinburgh    Edinburgh   UNITED KINGDOM

OAID 27

Subject area/topic: Ongoing Trial

Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke (MAAS) - A multicenter, randomized, open-label phase II trial.

Background Impaired glucose tolerance (IGT), defined as a 2-hour post load glucose level between 7.8 and 11.0 mmol/L, is present in one third of the patients with TIA or ischemic stroke, and is associated with a 2-fold increased risk of recurrent stroke. Whether pharmacological intervention reduces the risk of future cardiovascular events in these patients is unknown. Our recent study suggests that metformin is safe and improves glucose tolerance in patients with TIA or minor ischemic stroke and IGT, but often leads to gastro-intestinal side effects resulting in permanent discontinuation in 25%. Sitagliptin might be equally effective, but with fewer side effects. Objective We aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and IGT. We will assess whether a slow increase in dose of metformin and better support and information on this treatment will reduce the incidence of side effects. Methods MAAS is a phase II, multicenter, randomized, controlled, open-label trial with blinded outcome assessment. Hundred patients with a recent TIA or minor ischemic stroke and IGT will be randomized to receive either open-label metformin or sitagliptin or “no metformin” in a 1:1:2 ratio for 6 months. Metformin will be gradually increased in 6 weeks from 500 mg twice daily, to a daily dose of 2 times 1000 mg. Sitagliptin will be administered in a daily dose of 100 mg. Primary outcomes are tolerability and safety of metformin and sitagliptin and the baseline adjusted difference in 2-hour post-load glucose levels at 6 months. Secondary outcomes include baseline adjusted differences in 2-hour post-load glucose levels at 3 months, fasting glucose levels at 3 and 6 months, body mass index (BMI), waist circumference and percentage of patients with a normal glucose tolerance at 6 months. MAAS has been registered as NTR3196 in the Netherlands Trial Register. Trial status Inclusion will start in May 2012.

Graphic/Table:  
 

Presenting Author
S.  Fonville  
Erasmus Medical Center 
Rotterdam  
THE NETHERLANDS

Trialist: for the MAAS investigators

Co- Authors 2-15:
 A.A.M.  Zandbergen
Ikazia Hospital   Rotterdam   THE NETHERLANDS

L.J.M.M.  Mulder
Ikazia Hospital   Rotterdam   THE NETHERLANDS

H.F. Lingsma
Erasmus Medical Center   Rotterdam   THE NETHERLANDS

 D.W.J.  Dippel
Erasmus Medical Center   Rotterdam   THE NETHERLANDS

 P.J. Koudstaal
 Erasmus Medical Center   Rotterdam    THE NETHERLANDS

H.M.  den Hertog
Erasmus Medical Center   Rotterdam   THE NETHERLANDS

OAID 28

Subject area/topic: Ongoing Trial

PROSPECTIVE REGISTRY OF DECOMPRESSIVE SURGERY FOR CVT PATIENTS – DECOMPRESS – 2

Background: a retrospective registry and a systematic review of published cases showed that decompressive surgery is lifesaving in patients with acute severe cerebral venous thrombosis (CVT) and parenchymal lesions with impeding herniation. However, retrospective design and publication bias may overestimate the effect of the intervention. Objective: to describe in a prospective registry the vital and functional outcome of CVT patients treated by decompressive surgery, and to identify subgroups of CVT patients who benefit most from this surgery. Inclusion criteria: consecutive cases of CVT with parenchymal lesions treated by decompressive craniectomy or hematoma evacuation. Outcome at discharge and follow up: outcome will be measured at 6 and 12 months by an investigator not directly involved in the surgical intervention. The opinion of the patient and main caregiver concerning the results of surgery will be registered. Evaluation of cognition, mood, anxiety, Quality of life, caregiver burden and professional life: this evaluation will be performed at 6 and 12 months follow up using MMSE, HADS, EuroQol, Expanded Caregiver Strain Index and Post Stroke working Activity Questionnaires. Sample size: we aim to collect 100 patients with the contribution of 80 recruiting centres. Primary outcome and prognostic variables: the primary outcome is the modified Rankin Scale dichotomised between favourable (0-4) and unfavourable outcome (5 or death) at last available follow up. Prognostic variables will be age, delay to surgery, Glasgow Coma Scale score, fixed pupils, lesion characteristics, and type of surgery. Statistical analysis: for the analysis of the outcomes at last follow up, Cox regression analysis will be used and Hazard ratios with 95% CI calculated. Current status: inclusion started in January 2012, 41 centres are currently participating in the study and 3 patients are already included.

Graphic/Table:  
 

Presenting Author
J.M.  Ferro  
Department of Neurology, Hospital de Santa Maria, University of Lisbon 
Lisboa  
PORTUGAL

Trialist: ISCVT 2

Co- Authors 2-15:
 P.  Canhão
Department of Neurology, Hospital de Santa Maria, University of Lisbon   Lisboa   PORTUGAL

J.  Coutinho
Department of Neurology, Academic Medical Centre Amsterdam   Amsterdam   THE NETHERLANDS

J. Stam
Department of Neurology, Academic Medical Centre Amsterdam   Amsterdam   THE NETHERLANDS

 M.G.  Bousser
Department of Neurology, Hôpital Lariboisière       FRANCE

OAID 29

Subject area/topic: Ongoing Trial

EXtending oral antiCOAgulant treatment after acute Cerebral Vein Thrombosis (EXCOA-CVT): a cluster randomised study

Background: the optimal duration of anticoagulation after an acute cerebral venous thrombosis (CVT) is unknown. Objective: to compare the efficacy and safety of a short (3 months) versus long-term (12 months) oral anticoagulation (any type) policy for the prevention of venous thromboembolic events (VTEs) after an episode of CVT. All patients will be followed up for a total of 24 months to assess the risk of VTEs after stopping oral anticoagulation. Design: Multicentre, prospective study with a cluster allocation design for the therapeutic policy. Participating centres can either follow their preferred anticoagulation policy or be randomly allocated for one of the policy treatment options. Patients will follow a treatment of 3 or 12 months of oral anticoagulation according to the policy initially allocated to their centre, as soon as their acute clinical situation is stable and not more than 1 month after the CVT diagnosis. Patients included in the study will have follow-up appointments at 6, 12 and 24 months. Information about recurrent symptomatic CVT and other symptomatic venous or arterial thrombotic events will be recorded. Bleeding events will be evaluated at each follow-up visit. Participants: consecutive adult subjects with a MR/angiography confirmed recent CVT. Sample size: 450 patients per intervention group, to demonstrate a reduction of 50% in the risk of recurrent CVT, deep venous thrombosis or pulmonary embolism, from a basal risk of 10% to 5%, with an error of 0.05 and a power of 80% and 3% dropout rate Main outcome measures: symptomatic venous thromboembolic event (CVT, lower or upper limb deep vein thrombosis, pulmonary embolism and abdominal venous thrombosis). Safety endpoints will include bleeding events.

Graphic/Table:  
 

Presenting Author
J.M.  Ferro  
Department of Neurology, Hospital de Santa Maria, University of Lisbon 
Lisboa  
PORTUGAL

Trialist: ISCVT 2

Co- Authors 2-15:
 B.  Miranda
Department of Neurology, Hospital de Santa Maria, University of Lisbon   Lisboa   PORTUGAL

OAID 30

Subject area/topic: Ongoing Trial

The Stroke Oxygen Study (SO2S): a multi-centre, prospective, randomised, open, blinded-endpoint study of routine oxygen supplementation during the first 72 hours after a stroke

Introduction Hypoxia after stroke is common, often missed, and associated with worse outcome. Oxygen supplementation could prevent hypoxia and related brain damage and lead to better recovery from the stroke. However, a small clinical study of short-term fixed dose oxygen supplementation did not show overall benefit. Oxygen supplementation may interfere with mobilization and thus affect early rehabilitation. Since hypoxia is most likely to occur at night, restricting routine supplementation to night time may be better than continuous oxygen or no routine oxygen. Current guidelines on oxygen supplementation are not based on evidence from clinical trials and differ between countries and organizations. Aims: To determine if patients benefit from routine oxygen supplementation after stroke To establish whether nocturnal oxygen supplementation is as effective as, or more effective than, continuous oxygen supplementation. Method Inclusion criteria Patients with a clinical diagnosis of acute stroke who have no clear indication for and no clear contraindication against oxygen treatment are recruited within 24 h of hospital admission. Intervention for first 72 hours: 1. No routine oxygen supplementation 2. Oxygen per nasal cannula over night either 3L/min (if baseline oxygen saturation is 93% or below) or 2L/min (if baseline oxygen saturation is >93%) 3. Oxygen (as in 2) continuously (day and night) Assessments: 1 week by the local investigator (clinical examination, complications, compliance and NIHSS); 3, 6, and 12 months via postal questionnaire sent out by the trial centre (mRS, Barthel Index, EuroQuol, Nottingham EADL). Study size: 6600 subjects www.so2s.co.uk This project was funded by the NIHR Health Technology Assessment programme (project number 09/104/21). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

Graphic/Table:  
 

Presenting Author
C  Roffe  
ISTM, Keele University and North Staffordshire Combined Healthcare NHS Trust 
Stoke-on-Trent  
UNITED KINGDOM

Trialist: SO2S trial collaborators

Co- Authors 2-15:
 P.  Crome
North Staffordshire Combined Healthcare NHS Trust   Stoke-on-Trent   UNITED KINGDOM

R.  Gray
Birmingham University Clinical Trials Unit, University of Birmingham   Birmingham   UNITED KINGDOM

L. Handy
Stroke R Us   Stoke-on-Trent   UNITED KINGDOM

 P.  Handy
Stroke R Us   Stoke-on-Trent   UNITED KINGDOM

 P. Bell
 Stroke Assoication   Stafford    UNITED KINGDOM

S. J.  Pountain
North Staffordshire Combined Healthcare NHS Trust   Stoke-on-Trent   UNITED KINGDOM

B.  Kaambwa
University of Birmingham  Birmingham   UNITED KINGDOM

 J.  Belcher
Keele University   Stoke-on-Trent   UNITED KINGDOM

 S.  Jowett
University of Birmingham   Birmingham   UNITED KINGDOM

OAID 31

Subject area/topic: Ongoing Trial

AVERT: Ongoing Phase III, Multicentre, International Trial of Very Early Rehabilitation after Stroke

J. Bernhardt on behalf of the AVERT Trialists Collaboration Stroke Division, Florey Neuroscience Institutes, Melbourne Australia Background: Early and frequent out of bed activity (mobilisation) starting within <24 hours of stroke, may be an important component of effective stroke unit care. Within a multi-centre, single blind, randomised controlled trial, we hypothesise that early and frequent mobilisation will reduce death and disability and be cost effective. Methods: Medically stable patients within 24 hrs of stroke are included. Patients with severe pre-morbid disability and co-morbidities are excluded. Randomisation is stratified by site and stroke severity. Intervention is delivered by a nurse/physiotherapist, commences within 24 hours and continues for a maximum of 14 days. Control group patients receive standard care. Primary outcome is modified Rankin Scale at 3 months. Sample size is 2104 patients (n=1052 per group). Analyses will be intention to treat. Trial status: 47 hospitals are participating in Australia, New Zealand, Malaysia, Singapore and the United Kingdom. At end March 2012, 1229 patients (5.6% of all strokes) have been recruited. The main exclusion reason is that patients are admitted > 24 hours after stroke (40.3%). Mean age of participants is 70.5 (12.9) years with 47% having moderate-severe stroke. 1160 patients have completed 3 month follow up with 5 drop outs. Conclusion: The Data Monitoring Committee has met 8 times and no safety issues have been identified. We aim to complete recruitment in December 2014.

Graphic/Table:  
 

Presenting Author
J  Bernhardt  
Florey Neuroscience Institutes 
Heidelberg  
AUSTRALIA

Trialist: AVERT Trialists Collaboration

Co- Authors 2-15:
     
       

OAID 32

Subject area/topic: Ongoing Trial

CLOTS 3 - A randomised trial to establish the effectiveness of Intermittent Pneumatic Compression to prevent post stroke deep vein thrombosis (DVT)

Introduction: About 10% of immobile patients with stroke will develop a proximal DVT detectable on compression duplex ultrasound in the first month. The CLOTS trials 1&2 established that graduated compression stockings (GCS) do not reduce the risk of post stroke DVT. Anticoagulation, with heparins or low molecular weight heparin, reduce the risk of DVT but this benefit is largely offset by a three fold increased risk of bleeding. Intermittent Pneumatic Compression (IPC) is effective in surgical patients. Small RCTs in stroke suggest it is feasible in stroke patients although there are insufficient data to justify its routine use. The CLOTS trial 3 aims to test IPC in immobile stroke patients. Methods: These are based on those of the CLOTS 1 & 2. Immobile patients admitted to hospital within 3 days of an acute stroke can be randomised into the trial. Simple baseline data are collected via telephone or the web and the patient is randomised to Routine care + IPC or Routine care alone. The primary outcome is the presence of DVT in the popliteal vein or more proximal vein detected on either Duplex ultrasound or venography within 30 days of randomisation. Patients have a screening Duplex ultrasound of both legs between Day 7 and Day 10 and between Day 25 and Day 30. Data are collected at hospital discharge to monitor compliance and to identify in hospital complications, deaths and length of stay. At six months we establish patient's place of residence, functional status, current antithrombotic medication regimen and the quality of life. Conclusions: Funding has been obtained from the NHS R&D Health Technology Assessment Board. The main phase of the trial started on 1st April 2010 and now includes 100 UK centres and aims to enrol 2800 patients. The trial has been adopted by the UK Stroke Research Network.

Graphic/Table:  
 

Presenting Author
C.A.  Williams  
University of Edinburgh 
Edinburgh  
UNITED KINGDOM

Trialist: CLOTS Trial Collaboration

Co- Authors 2-15:
 M.S.D.  Dennis
University of Edinburgh   Edinburgh   UNITED KINGDOM

OAID 33

Subject area/topic: Ongoing Trial

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST) – Pilot Phase

Introduction: Alteplase is currently the only approved thrombolytic drug in acute ischaemic stroke <4.5 hours from symptom onset. However, pharmacokinetic limitations and possible neurotoxicity of alteplase make an improved thrombolytic agent for ischaemic stroke desirable. ATTEST is a pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke, using imaging biomarkers to reduce sample size, intended to inform the design of a definitive, randomized controlled multicentre trial with clinical endpoints. Methods: ATTEST is a single-centre Prospective Randomized Open Blinded End-point (PROBE) trial in thrombolysis-eligible patients <4.5h after onset, who are randomized to receive tenecteplase 0.25mg/kg or alteplase 0.9mg/kg (to a maximum possible weight of 100kg in each case). Baseline imaging comprises Non-contrast CT, CT perfusion (CTP) and CT angiography (CTA); repeat CT head and intracranial CTA are acquired 24 – 48 hours post stroke. The primary outcome measure is percent penumbral salvage at 24 – 48 hours (initial CTP – defined penumbra volume versus 24 – 48 hour CT infarct volume). Secondary outcomes include proportion of patients exhibiting recanalisation on 24 – 48h CTA ; early clinical improvement on NIHSS; symptomatic ICH incidence; proportion of patients with mRS 0-1 at days 30 and 90; home time; and mortality. Results: To date, 24 patients have been randomized, of which 14 (58%) were male. The mean (±SD) age was 71.9 ± 8.2 years. The median (IQR) baseline NIHSS was 12 (10), and onset to treatment time was 190 ± 45 mins. Risk factor prevalence was hypertension in 13/24 (54%), diabetes 4 (17%), atrial fibrillation 7 (29%), previous stroke or TIA 5 (21%). Conclusion: Recruitment to the study is ongoing. Recruitment rates suggest that rapid recruitment to trials with two active treatment arms is feasible.

Graphic/Table:  
 

Presenting Author
X.  Huang  
Institute of Neuroscience and Psychology, University of Glasgow 
Glasgow  
UNITED KINGDOM

Trialist:  

Co- Authors 2-15:
 F.  Moreton
Institute of Neuroscience and Psychology, University of Glasgow   Glasgow   UNITED KINGDOM

D.  Kalladka
Institute of Neuroscience and Psychology, University of Glasgow   Glasgow   UNITED KINGDOM

K. Muir
Institute of Neuroscience and Psychology, University of Glasgow   Glasgow   UNITED KINGDOM

OAID 34

Subject area/topic: Ongoing Trial

'Preventive Antibiotics in Stroke Study' (PASS)

Rationale: Post-stroke infections occur in 30% of all patients and even 45% in the ICU-admitted subgroup. They are a strong and independent predictor of poor outcome. As shown in our meta-analysis, preventive antibiotic therapy lowers the infection rate after stroke. However, a sufficient large phase-III-RCT evaluating its effect on clinical outcome has not been performed yet. Ceftriaxone, an off-patent antibiotic, has a broad defence against the bacteria that cause the most common post-stroke infections. Aim: To investigate whether the preventive use of ceftriaxone improves functional outcome in patients with stroke. Design: We will conduct a multicentre prospective, randomised, open-label, blinded endpoint trial in which preventive ceftriaxone treatment added to standard care will be compared with standard care without preventive ceftriaxone. Study: Adult patients with stroke (ischaemic and haemorrhagic), with an onset of symptoms within 24 hours before presentation and with a score ≥ 1 on the National Institutes of Health Stroke Scale are included. A total of 3200 patients will be randomly assigned into two groups of 1600 patients. The treatment group receives standard care plus ceftriaxone at a dose of 2000 mg, given every 24 h intravenously for four-days; the control group will receive standard care. Outcomes: Primary endpoint is the functional outcome after a three-month follow-up on the modified Rankin Scale (mRS), dichotomised as a favourable (0–2) or unfavourable (3–6) outcome. Secondary outcome measures will be death rate at discharge and three-months, infection rate during hospital admission, length of hospital admission, volume of post-stroke care, total use of antibiotics during follow-up, functional outcome using the ordinal scoring range of the mRS, and quality-adjusted life years and costs. Study Proceedings: Medical ethical approval was obtained in May 2010. The first inclusion was on 4 July 2010. On 23 April 2012, 1059 patients were included. Up-to-date statistics are available at www.passamc.nl

Graphic/Table:  
 

Presenting Author
J-D.  Vermeij  
Academic Medical Center (AMC) 
Amsterdam  
THE NETHERLANDS

Trialist: PASS Investigators Collaboration

Co- Authors 2-15:
 W.F.  Westendorp
Academic Medical Center (AMC)   Amsterdam   THE NETHERLANDS

D.  van de Beek
Academic Medical Center (AMC)   Amsterdam   THE NETHERLANDS

P.J. Nederkoorn
Academic Medical Center (AMC)   Amsterdam   THE NETHERLANDS

OAID 35

Subject area/topic: Ongoing Trial

Intermittent versus permanent bladder catheterization in acute stroke patients

Background: bladder function alterations are a common finding in early phase of ischaemic and haemorrhagic stroke patients. There is no consensus on how to use the bladder catheter, because both intermittent catheterization (IC) and permanent catheterization (PC) have potential advantages and pitfalls. We aimed to evaluate bladder function recovery in early period of stroke patients, using post micturition residual, and to evaluate the incidence of urinary infections (UI) and the quality of life (QOL) during hospitalization. Methods: we planned a pilot randomized trial between IC and PC. We calculated that 50 patients are needed to pick up a difference of 100 cc in post micturition residual after 7 days. If the patients can not urinate adequately in the first 24 hours of hospitalization, they are randomized to IC or PC. At the seventh day the quantification of post micturition residual is performed using bladder scanner echography and an uroflussimetry is programmed. Results: so far we randomized 17 patients in Città di Castello and Branca Stroke Units. The results of the study will be available in October 2012. Conclusion: even in SPREAD or Neurology latest guidelines, there is no consensus about the management of altered urinary function in the acute phase of stroke patients. Moreover there is no data about the risk of incidence of UI, correlation with clinical recovery and QOL in catheterized patients. In the present study, we detect bladder function recovery using post micturition residual, calculated with bladder scanner echography in IC and PC patients. Based on the future results, we propose to apply our approach in the routine management of Stroke Units’ patients in order to improve the management of urinary dysfunction.

Graphic/Table:  
 

Presenting Author
A.  Mattioni  
U.O. Neurologia, ASL1 Umbria 
Citta di Castello  
ITALY

Trialist:  

Co- Authors 2-15:
 C.  Menichetti
U.O. Neurologia, ASL1 Umbria   Citta di Castello   ITALY

S.  Cenciarelli
U.O. Neurologia, ASL1 Umbria   Città di Castello   ITALY

T. Mazzoli
U.O. Neurologia, ASL1 Umbria   Citta di Castello   ITALY

 E.  Gallinella
U.O. Neurologia, ASL1 Umbria   Citta di Castello   ITALY

 L.M. Greco
 U.O. Neurologia, ASL1 Umbria   Citta di Castello    ITALY

R.  Condurso
U.O. Neurologia, ASL1 Umbria   Citta di Castello   ITALY

I.  Sicilia
U.O. Neurologia, ASL1 Umbria  Citta di Castello   ITALY

 S.  Ricci
U.O. Neurologia, ASL1 Umbria   Citta di Castello   ITALY

OAID 36

Subject area/topic: Ongoing Trial

MR CLEAN - Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (NTR1804)

Rationale: Ischemic stroke is often caused by embolic occlusion of proximal intracranial arteries. The effect of intravenous alteplase is limited in these patients. Endovascular treatment increases the likelihood of recanalization, but the effect of treatment and functional outcome is not certain. Aim: The main purpose of the Multicenter Randomized Clinical trial of Endovascular treatment for acute ischemic stroke in the Netherlands (MR CLEAN) is to assess the effect on functional outcome and safety of endovascular treatment in patients with a proximal occlusion of the anterior circulation. Design: MR CLEAN is a pragmatic phase III multicenter randomized clinical trial with blinded outcome assessment. The intervention contrast is endovascular treatment with trombolytics (urokinase or alteplase) and/or mechanical trombectomy versus no endovascular treatment. The choice of endovascular treatment modality for each patient is left to the discretion of the local investigator and treating physicians. Background medical management is delivered according to national standards and guidelines. It may include intravenous alteplase within the first 4.5 hours after onset. Outcomes: The primary outcome is the score on the modified Rankin scale (mRS) 90 days after inclusion in the study. Secondary outcomes are the NIHSS score at 24 hours, vessel patency, infarct size, and the occurrence of major bleeding. The randomization will be stratified for use of intravenous alteplase, planned treatment modality (intra-arterial thrombolysis, mechanical trombectomy or both) treatment center and stroke severity. The effect of treatment will be estimated by means of the ordinal logistic regression (shift analysis). In total, 500 patients will be included in the trial. Discussion: MR CLEAN is a pragmatic trial. Inclusion of patients will take 4 years and has started in December 2010. As of April 2012, 11 participating centers are active and 97 patients have been included.

Graphic/Table:  
 

Presenting Author
D  Beumer  
Cardiovascular Research Institute Maastricht, Department of Neurology Maastricht University Medical Center 
Maastricht  
THE NETHERLANDS

Trialist: for the MR CLEAN trialists

Co- Authors 2-15:
 R.J.  van Oostenbrugge
Department of Neurology Maastricht University Medical Center   Maastricht   THE NETHERLANDS

W.H.  van Zwam
Department of Radiology Maastricht University Medical Center   Maastricht   THE NETHERLANDS

P Fransen
Department of Neurology Erasmus MC University Medical Center Rotterdam   Rotterdam   THE NETHERLANDS

 A  van der Lugt
Department of Radiology of the Erasmus MC University Medical Center Rotterdam   Rotterdam   THE NETHERLANDS

 Y.B.W.E.M. Roos
 Department of Neurology Academic Medical Center Amsterdam   Amsterdam    THE NETHERLANDS

C.B.  Majoie
Department of Radiology Academic Medical Center Amsterdam   Amsterdam   THE NETHERLANDS

D.W.J.  Dippel
Department of Neurology Erasmus MC University Medical Center Rotterdam  Rotterdam   THE NETHERLANDS

OAID 37

Subject area/topic: Ongoing Trial

The Desmoteplase DIAS-3 and DIAS-4 Clinical Trials: an Important Milestone Passed

Introduction Desmoteplase is the only thrombolytic agent in late stage development for acute ischaemic stroke, despite a high unmet need for more treatment options. Desmoteplase has high fibrin selectivity, no apparent neurotoxicity or negative effect on the blood-brain barrier. Two large randomized, double-blind, placebo-controlled, phase III trials are ongoing worldwide: DIAS-3 and DIAS-4 (n=800 in total). Objective and Design The objective of DIAS-3 and DIAS-4 is to evaluate the safety and efficacy of a single IV bolus injection of 90 μg/kg desmoteplase given 3-9 hours after onset of ischaemic stroke (NIHSS 4-24, age 18-85 years). Patients are selected with occlusion or high-grade stenosis (TIMI 0-1) in proximal cerebral arteries, assessed by CT or MR angiography. The selection is based on the results of post-hoc analyses on data from DEDAS, DIAS and DIAS-2. Compared to placebo, desmoteplase treatment was favourable in patients presenting with TIMI 0–1 at baseline (odds ratio, 4.144; 95% CI, 1.40–12.23), while there was no desmoteplase treatment benefit in patients presenting with TIMI 2–3 (odds ratio, 1.109) [Fiebach et al. Stroke 2012; April 3]. The primary efficacy outcome of DIAS-3 and DIAS-4 is the modified Rankin Scale score at Day 90. Other outcome measures include NIHSS score at Day 90, recanalisation in patients with follow-up angiography, clinical outcome in patients with core-lesion <25 mL, clinical outcome in patients with perfusion/diffusion mismatch, and various safety parameters. Status An independent data review by the Data Monitoring Committee in October 2011, revealed no safety issues and they encouraged to continue to enroll suitable patients. DIAS-3 is expected to be completed in the first half of 2013, and submission of both trials to health authorities expected in first half of 2014. The important milestone of enrolling more than 50% of the required number of patients was passed at the end of 2011.

Graphic/Table:  
 

Presenting Author
R.  von Kummer  
Univ Hospital Carl Gustav Carus, Technical University 
Dresden  
GERMANY

Trialist: The DIAS-3 and DIAS-4 Study Group

Co- Authors 2-15:
 G.W.  Albers
Dept of Neurology, Stanford Univ Stroke Center   Palo Alto, CA   USA

OAID 38

Subject area/topic: Ongoing Trial

Basilar Artery International Cooperation Study: the BASICS trial

Background Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). 1 Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that IAT is superior to IVT in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study. We concluded a definitive RCT was needed. 1.Schonewille, WJ et al. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry. Lancet Neurol. 2009 Aug;8(8):724-30. Methods Design: multi-center open label randomised controlled phase III treatment trial. Study population: patients with CTA or MRA confirmed basilar artery occlusion treated with IVT. Target: 750 patients. Intervention: patients will be randomised between additional IA therapy followed by maximum supportive care versus maximum supportive care alone. IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IA therapy within 6 hours. Main study endpoint: favourable outcome at day 90 defined as a modified Rankin Score of 0-3. Objective Evaluate the efficacy and safety of additional IA therapy after IV thrombolysis in patients with basilar artery occlusion. Contact e.van.der.hoeven@antoniusziekenhuis.nl w.schonewille@antoniusziekenhuis.nl www.basicstrial.com

Graphic/Table: http://www.eurostroke.org/OAID_38.html  
 

Presenting Author
E.  van der Hoeven  
St. Antonius Hospital Nieuwegein 
Nieuwegein  
THE NETHERLANDS

Trialist: http://www.trialregister.nl NTR2617

Co- Authors 2-15:
 W.J.  Schonewille
St. Antonius Hospital Nieuwegein   Nieuwegein   THE NETHERLANDS

J.A.  Vos
St. Antonius Hospital Nieuwegein   Nieuwegein   THE NETHERLANDS

A. Algra
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

 L.J.  Kappelle
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

OAID 39

Subject area/topic: Ongoing Trial

QUALITY OF LIFE, READMISSION/RECURRENCE AND MORTALITY AFTER ISCHEMIC STROKE: PREDICTIVE SCALES

Background: Stroke results in a significant impairment on the quality of life (QoL), but the predictors have not been identified by appropriate analysis tools. Aim: The aim of this study is to analyze the change in quality of life, recurrence and mortality after the first-ever ischemic stroke. Specifically, we seek to: 1) Identify the predictors of change on QoL during the first year after stroke by spanish validated stroke specific scales (ECVI-38), available for aphasic patients. 2) Identify the readmission causes as well as the recurrence and mortality risk factors, individually, one year after the first-ever ischemic stroke. Method: Prospective, multicenter cohort study. Patients will be evaluated on three occasions (on admission, and 3 and 12 months after stroke). Sociodemographic and clinical variables will be collected from the hospital records to identify predictors. Outcome variables will be collected by personal interviews and medical records checking. A total of 1900 patients are expected to be recruited during a 3-year period. Statistical analysis: a logistic regression analysis will be employed to identify the predictors for each of the objectives (QoL, readmissions, recurrence and mortality) that will allow to elaborate predictive scales useful in clinical practice. Discussion: Stroke care investigation should include creation of predictive models that can be used in everyday practice to identify changes in health-related quality of life and patients with the highest risk of developing a poor outcome (readmission, recurrence and mortality risk factors). This will be followed by implementation of appropriate measures that will result in lower health care costs and in a better patient management.

Graphic/Table:  
 

Presenting Author
A.C.  Pinedo Brochado  
Department of Neurology. Hospital de Galdakao-Usansolo.  
Galdakao Usansolo  
SPAIN

Trialist: A.C. Pinedo, I. Kortazar and J.C. García-Moncó

Co- Authors 2-15:
 I.  Kortazar Zubizarreta
Department of Neurology. Hospital de Galdakao-Usansolo.    Galdakao Usansolo   SPAIN

J.C.  García-Moncó Carra
Department of Neurology. Hospital de Galdakao-Usansolo.    Galdakao Usansolo   SPAIN

OAID 40

Subject area/topic: Ongoing Trial

The ALIAS (Albumin in Acute Stroke) Part 2 Trial: a Phase III Multicenter Randomized Placebo-Controlled Trial to Assess the Neuroprotective Efficacy of High-Dose Albumin in Acute Ischemic Stroke

The trial’s primary objective is to ascertain whether high-dose human albumin (ALB) therapy (25% solution, total dose 2.0 g/kg [8 ml/kg, not to exceed 750 ml; 2-h infusion]) begun within 5 hours of stroke onset increases the proportion of subjects with favorable outcome compared to placebo (isotonic saline) therapy. Standard-of-care thrombolytic therapies are permitted. A favorable primary outcome is defined as NIH Stroke Scale score of 0-1 and/or modified Rankin Scale score of 0-1 at 3 months post-randomization. Secondary clinical and quality-of-life measures are assessed at 1, 3, 6, 9 and 12 months. A sample size of 1,100 subjects, randomized 1:1 to ALB or placebo, is required. This sample size ensures 90% power in detecting an absolute treatment effect of 10% with alpha = 0.05, and sufficient (80%) power to detect a thrombolysis x treatment interaction. Inclusion criteria include: age 18 through 83 years; baseline NIHSS score of 6 or greater; initiation of ALB/placebo therapy within 5 h of stroke onset; and informed consent. Major exclusion criteria include: congestive heart failure (CHF), cardiac surgery or myocardial infarction (MI) in the past 6 months; MI or CHF on admission; acute arrhythmia with hemodynamic instability; pulmonary edema; and acute or chronic lung disease requiring O2 therapy. A normal serum troponin level is required for inclusion. It is mandated that no more than 4,200 ml of IV fluids be administered during the first 48 hours. Administration of a loop diuretic (typically, furosemide 20 mg IV) is mandatory between 12-24 hours. Progress: The trial is currently ongoing at around 70 clinical sites in the United States, Canada, and Israel, including U.S. sites participating via the NIH-funded NETT Network. Shortly, 4 sites in Finland will join the trial. As of late April, 2012, 741 subjects (67% of our target) have been enrolled. An independent Data and Safety Monitoring Committee reviews the trial’s progress at 6-month intervals.

Graphic/Table:  
 

Presenting Author
M.D.  Ginsberg  
University of Miami Miller School of Medicine 
Miami  
USA

Trialist:  for the ALIAS Trialists

Co- Authors 2-15:
 M.D.  Hill
University of Calgary   Calgary   CANADA

Y.Y.  Palesch
Medical University of South Carolina   Charleston   USA

B.D. Waldman
Medical University of South Carolina   Charleston   USA

 R.H.  Martin
Medical University of South Carolina   Charleston   USA

 S.D. Yeatts
 Medical University of South Carolina   Charleston    USA

C.S.  Moy
National Institute of Neurological Disorders and Stroke   Rockville   USA

D.  Tamariz
University of Miami Miller School of Medicine  Miami   USA

 K.J.  Ryckborst
University of Calgary   Calgary   CANADA

 W.  Barsan
University of Michigan   Ann Arbor   USA

OAID 41

Subject area/topic: Ongoing Trial

Magnetically Enhanced Diffusion (MED) for Improved Efficacy of Thrombolytic Therapy in Acute Ischemic Stroke—A Prospective First in Man Clinical Study

BACKGROUND: Preclinical studies have shown that the MED system developed by Pulse Therapeutics, Inc. appears efficient in delivering co-administered agents by affecting the fluid dynamics in targeted occluded arteries. The system is an adjunct to IV rt-PA, and is composed of biologically-safe magnetic particles and a portable magnet system for use in the ED. Preclinical studies support strong efficacy and safety of the MED technology. The primary objective of this feasibility study is to establish the safety (sICH at 24 hours post onset) of the technology when used as an adjunct to IV rt-PA for moderate-to-large (10≤NIHSSS≤24, occlusion confirmed by CTA) ischemic strokes within three hours of acute onset. METHODS: 10 subjects with moderate-to-large ischemic strokes between ages 18-80 will be enrolled at 2 centers in Australia (Box Hill and John Hunter hospitals). All candidates must possess an intracranial arterial occlusion of the middle cerebral, anterior cerebral, internal carotid, posterior cerebral or distal basilar artery confirmed by CTA or MRA, and must be administered rt-PA within 3 hours of acute onset. Artery selection is input into the MED system and the magnet energized for the entirety of the rt-PA infusion, plus 30min. The primary endpoint is safety as assessed by incidence and evaluation of any adverse effects associated with the investigational procedure compared with historical controls treated with rt-PA alone. The secondary endpoint is the degree of recanalization (partial and complete) and reperfusion as measured by CTA at 2-4hrs and MRI at 24±6hrs post MED therapy. TIMI Grade Flow of 2 or 3 will be considered responsive to treatment. CONCLUSIONS: This feasibility trial will attempt to establish the safety (sICH) and recanalization efficacy of the MED technology as an adjunctive therapy to standard-dose IV rt-PA. As of April 24th, 2012, Box Hill and John Hunter hospitals have been qualified to begin enrollment.

Graphic/Table:  
 

Presenting Author
C.  Bladin  
Monash University 
Melbourne  
AUSTRALIA

Trialist:  

Co- Authors 2-15:
 C.  Levi
University of Newcastle   Newcastle   AUSTRALIA

M.  Parsons
University of Newcastle   Newcastle   AUSTRALIA

OAID 42

Subject area/topic: Ongoing Trial

Optimising the Analysis of Cognition Collaboration (OA-Cog)

Rationale: Over 800,000 people suffer with dementia in the UK. The evidence base for the treatment of cognitive decline and dementia is small. One reason for this may be that the measures used to assess cognition in clinical trials are not sensitive to change and/or the analyses used are suboptimal. OA-Cog aims to identify the most efficient cognitive measurement and analysis technique for cognition data and dementia in randomised controlled trials. Sample size in clinical trials is an important issue. A reduced sample size will allow trials to be conducted faster and use fewer resources. OA-Cog aims to assess the implication of choosing particular methods of analysis and also adjusting for baseline prognostic factors on sample size. Design: Chief investigators of randomised controlled trials with cognitive assessments are asked to share individual patient data from their trials. Variables requested include baseline prognostic factors, treatment group, cognitive measures (e.g. Mini Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale cognitive subscore (ADAS-cog)) and other outcome measures (e.g. death, dementia). Data are then analysed using various endpoints (e.g. mean MMSE score at end of trial, MMSE score as a gradient over time) and statistical methods (e.g. Wilcoxon rank-sum test, repeated measures ANOVA) in order to identify the most efficient. Trial Status: As of 26th April 2012, data from 18 clinical trials, with a total of 43,135 patients have been shared. The OA-Cog project is currently seeking further clinical trial data. Contact Information: E-mail: cheryl.renton@nottingham.ac.uk Telephone: +44 (0) 115 823 1670

Graphic/Table:  
 

Presenting Author
C.J.  Renton  
University of Nottingham 
Nottingham  
UNITED KINGDOM

Trialist: Optimising the Analysis of Cognition Collaboration

Co- Authors 2-15:
 P.M.W.  Bath
University of Nottingham   Nottingham   UNITED KINGDOM

OAID 43

Subject area/topic: Ongoing Trial

Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB)

Aim: Spasms after subarachnoid hemorrhage (SAH) are a major complication of the disease. Clinical symptoms (DIND = delayed ischemic neurological deficit) and transcranial Doppler (TCD) detection of spasms are often not clearly related. Currently there is no method available for predicting DIND with high accuracy. Recent studies using perfusion CT show a correlation between perfusion abnormalities and the development of DIND. In our prospective monocentric ongoing trial we use perfusionsonography to predict DIND. Methods: Consecutive SAH patients were prospectively investigated in 2-day intervals within the first 13 days after SAH. Conventional TCD, contrast agent based perfusionsonography, and clinical course (NIHSS) were assessed. Transcranial real-time perfusionsonography (ultrasound system Philips iU22: axial investigation plane, 10 cm investigation depth, 2.4 ml of SonoVue™, replenishment kinetics, off-line analysis [QLAB™]: perfusion parameters A and beta in 4 defined ROI) was used. At least weekly a cranial CT was performed. Results: The study started in January 2012. Up to date (4/2012) 8 SAH patients were included in the study (5 women, mean age: 59,1 years [median 58.5]), median Hunt and Hess score: 1.5). In two cases transtemporal acoustic bone window was not sufficient. Brain infarction was diagnosed in two of the 6 patients. Perfusionsonography showed a complete perfusion deficit in the area of infarction (MCA- and ACA-territory, each). We present the clinical data, the results of the ultrasound studies (TCD and perfusionsonography), and the CCT findings. Conclusions: First results of our prospective ongoing trial showed that perfusionsonography enables direct visualization of cerebral infarction after SAH in the early stages at the patient`s bedside. (ClinicalTrials.gov ID: NCT01537263)

Graphic/Table:  
 

Presenting Author
G.  Seidel  
Dept. of Neurology, Asklepios Klinik Nord 
Hamburg  
GERMANY

Trialist: Ultrasound brain perfusion study group

Co- Authors 2-15:
 B.  Fischer
Dept. of Neurology, Asklepios Klinik Nord   Hamburg   GERMANY

D.  Kücken
Dept. of Neurology, Asklepios Klinik Nord   Hamburg   GERMANY

OAID 44

Subject area/topic: Ongoing Trial

The Field Adminstration of Stroke Therapy- Magnesium (FAST-MAG) Phase 3 Trial

Design: Multicenter, randomized, double-blind, placebo-controlled phase 3 trial Specific Aim: To demonstrate that paramedic-initiated intravenous magnesium sulfate within 2 hours of symptom onset improves the longterm functional outcome of hyperacute stroke patients Planned enrollment: 1700 patients Participating Sites: 355 rescue vehicles and up to 65 receiving hospitals in Los Angeles and Orange Counties Target Population: Ambulance-arriving patients with hyperacute stroke, both cerebral infarction and intracerebral hemorrhage Inclusion Criteria: 1) Suspected stroke identified by the Los Angeles Prehospital Stroke Screen (LAPSS), 2) Age 40-95, inclusive, 3) Last known well time within 2 hours of treatment initiation, 4) Deficit present for ≥ 15 minutes Intervention: Paramedic field loading dose: 4 grams magnesium sulfate over 15m or matched placebo. In hospital maintenance dose: 16 grams Mg over 24h or matched placebo Primary Endpoint: Modified Rankin Scale 3 months post stroke, Cochran-Mantel-Haenszel test to detect shift in distribution over all 7 strata. Funding: NIH-NINDS Award U01 NS44364 Trial Progess (29.04.2012): Number of patients=1542 (91% of target), estimated completion date December 2012. Median time from onset of symptoms to therapy initiation: 46 minutes.

Graphic/Table:  
 

Presenting Author
N.  Sanossian  
University of Southern California 
Los Angeles  
USA

Trialist: FAST-MAG Investigators

Co- Authors 2-15:
 J.L.  Saver
UCLA   Los Angeled   USA

M.  Eckstein
USC   Los Angeles   USA

S Stratton
UCLA   Los Angeles   USA

 F.R.  Pratt
Los Angeles County Fire Department   Los Angeles   USA

 S. Hamilton
 Stanford University   Palo Alto    USA

R.  Conwit
NIH   Bethesda   USA

D.S.  Liebeskind
UCLA  Los Angeles   USA

 G.  Sung
USC   Los Angeles   USA

 P.  Lyden
Cedars Sinai   Los Angeles   USA

S. Starkman
UCLA    Los Angeles   USA

OAID 45

Subject area/topic: Ongoing Trial

Efficacy of Nitric Oxide in Stroke (ENOS) Trial - A Prospective Randomised Controlled Trial in Acute Stroke

Rationale: Acute hypertension is associated with a poor outcome after stroke. No large trials have assessed the effect of altering BP during the acute phase of stroke on outcome. We are testing whether nitric oxide, a multimodal molecule given as glyceryl trinitrate (GTN), is safe and effective in improving outcome after acute stroke. Furthermore, around half of all patients admitted with acute stroke are taking antihypertensive therapy immediately prior to the stroke. No data exist as to whether it is beneficial or safe to stop or continue this treatment during the acute phase. Design: ENOS is a prospective, international, multicentre, randomised, parallel-group, blinded, controlled trial. 3,500 - 5,000 ischaemic or haemorrhagic stroke patients with systolic BP 140-220 mmHg, and within 48 hours of onset will be included. Subjects will be randomised to 7 days of single-blind treatment with transdermal GTN or control. Those patients taking prior antihypertensive therapy will also be randomised to continue or temporarily stop this for 7 days. ENOS is conducted over a secure internet site. The primary outcome is modified Rankin Scale at 90 days which is carried out by a blinded assessor. The analysis will be by intention to treat. Trial status: As at 26th April, 2012, 2990 patients had been recruited from 155 centres (Australia, Canada, China, Denmark, Egypt, Georgia, Hong Kong, India, Italy, Malaysia, New Zealand, Philippines, Poland, Republic of Ireland, Romania, Singapore, Spain, Sri Lanka and UK). More centres welcome to join. Funding: The Medical Research Council. Contact information: http://www.enos.ac.uk , E-mail: enos@nottingham.ac.uk, Telephone: +44 (0)115 823 1770

Graphic/Table:  
 

Presenting Author
P.M.W.  Bath  
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road 
Nottingham  
UNITED KINGDOM

Trialist:  

Co- Authors 2-15:
 C.  Renton
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road   Nottingham   UNITED KINGDOM

S.  Utton
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Raod   Nottingham   UNITED KINGDOM

OAID 47

Subject area/topic: Ongoing Trial

Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS). A randomised controlled trial

Rationale: The risk of recurrence is greatest immediately after stroke or TIA. Existing prevention strategies (antithrombotic, lipid/blood pressure lowering, endarterectomy) reduce, not abolish, further events. Dual antiplatelet therapy – aspirin & clopidogrel (AC) for ischaemic heart disease, aspirin & dipyridamole (AD) for stroke, is superior to aspirin monotherapy. We hypothesise that triple antiplatelet therapy (ACD) will be superior to current guideline therapy (AD or C) in patients at high-risk of recurrence, providing bleeding does not become excessive. Design: TARDIS is a multicentre, parallel-group, prospective, randomised, open-label, blinded-endpoint, controlled trial. In the start-up phase, we will assess over 3 years the safety, tolerability and feasibility of intensive antiplatelet therapy (ACD) versus guideline therapy given for 1 month in up to 1,000 patients with acute stroke/TIA. The main phase will then assess the safety and efficacy of intensive therapy in up to 4,100 patients. The primary outcome is ordinal stroke severity (fatal/severe non-fatal/mild/TIA/none) at 90 days. Secondary outcomes include death, myocardial infarction (MI), vascular events, function, bleeding, serious adverse events; sub-studies will assess cerebral emboli and platelet function. Trial status: The trial started in April 2009. As of 30th April, 2012, 738 patients have been recruited from 56 centres within the UK Stroke Research Network. Funding: The British Heart Foundation Contact Information: Website: http://www.tardistrial.org E-mail: tardis@nottingham.ac.uk Telephone: +44 (0)115 8230210

Graphic/Table:  
 

Presenting Author
P.M.W.  Bath  
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road 
Nottingham  
UNITED KINGDOM

Trialist:  

Co- Authors 2-15:
 C.  Renton
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road   Nottingham   UNITED KINGDOM

M.J.  Adrian
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road   Nottingham   UNITED KINGDOM

OAID 48

Subject area/topic: Ongoing Trial

PODCAST: Prevention Of Decline in Cognition After Stroke Trial: a factorial randomised trial of blood pressure and lipid lowering

Rationale: Stroke and dementia are common, economically costly to society, and devastating to patients and their family. Elevated BP and cholesterol are common after stroke and may be associated with increasing cognitive decline. Although BP-lowering post-stroke may reduce cognitive decline, there is little evidence that lipid lowering is effective in preventing cognitive decline. Critically, it is unknown whether BP and cholesterol should be lowered intensively, or moderately as per current guidelines. The trial aim is to determine if intensive BP and/or lipid lowering therapy after stroke is better in preventing cognitive decline, compared to current guideline treatment. Design: PODCAST is a prospective, randomised, open-label, blinded end-point, controlled, partial factorial, phase IV trial. The start up phase will assess feasibility of the study over 3 years in 600 patients. The main phase will assess the efficacy of intensive treatment in a further 2,800 patients over 8 years in total. The target Systolic Blood Pressure is <125 mmHg for the intensive BP lowering group and <140 mmHg for the guideline group. For the intensive lipid lowering group the target Low Density Lipoprotein-Cholesterol (LDL-C) is <2 mmol/L and <3 mmol/L for the guideline group. The primary outcome is Addenbrooke’s Cognitive Examination. Secondary outcomes include vascular events, quality of life, functional outcome, depression and death. Trial Status: The trial has UK Ethics and NHS RD approvals and has recruited 27 patients to date. Funding: The start-up phase is funded jointly by The Stroke Association UK and Alzheimer’s Society UK. Contact Information: Website: http://www.podcast-trial.org/ E-mail: podcast@nottingham.ac.uk Telephone: +44 (0) 115 8231671

Graphic/Table:  
 

Presenting Author
P.M.W.  Bath  
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road 
Nottingham  
UNITED KINGDOM

Trialist:  

Co- Authors 2-15:
 C.  Correia
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road   Nottingham   UNITED KINGDOM

L.  Stokes
University of Nottingham, Division of Stroke, Clinical Sciences Building, Hucknall Road   Nottingham   UNITED KINGDOM

OAID 49

Subject area/topic: Ongoing Trial

The 2nd European Carotid Surgery Trial (ECST-2)

BACKGROUND: Randomized trials some years ago established the benefit of carotid endarterectomy (CEA) for moderate and severe carotid stenosis in symptomatic and asymptomatic patients. A risk model derived from the European Carotid Surgery Trial showed that only patients with a high risk of stroke on medical therapy benefit from CEA. For many patients there is neither clear benefit nor harm from CEA. Medical therapy to prevent stroke in patients with carotid disease has improved considerably since these original trials were concluded, with more widespread use of statins, more active lowering of blood pressure and more effective antiplatelet agents. Therefore optimized medical therapy (OMT) using up-to-date regimes may obviate the need for CEA in many patients with carotid disease. We therefore designed ECST-2 to address the question: is OMT alone equally efficient in the long-term prevention of stroke compared with CEA and OMT combined in patients at low and intermediate risk for stroke? METHODS: ECST-2 is an international, multicentre, randomised, controlled, open, prospective clinical trial. Asymptomatic or symptomatic patients with carotid stenosis (> 50% by NASCET criteria) suitable for CEA with a low or intermediate Carotid Artery Risk (CAR) score will be randomized between OMT alone or CEA and OMT combined. OMT will include adjustment to achieve target blood pressure and cholesterol levels. The CAR score will estimate the 5 year ipsilateral stroke risk of patients based on their demographic characteristics. The trial has the primary outcome of long term survival free any stroke, MI or procedural death attributed to carotid revascularisation. Secondary outcome measures include cerebral infarction and haemorrhage on MRI, disability, cognitive decline, and economic measures. PROGRESS: Randomisation in ECST-2 commenced in March 2012 and we are currently recruiting centres. FUNDING: The trial is funded by a grant from the UK National Institute for Health research.

Graphic/Table:  
 

Presenting Author
R.L.  Featherstone  
UCL Institute of Neurology 
London  
UNITED KINGDOM

Trialist: The 2nd European Carotid Surgery Trial

Co- Authors 2-15:
 F.  Kennedy
UCL Institute of Neurology   London   UNITED KINGDOM

M.M.  Brown
UCL Institute of Neurology   London   UNITED KINGDOM

OAID 50

Subject area/topic: Ongoing Trial

The Enhanced Control of Hypertension ANd Thrombolysis strokE StuDy (ENCHANTED): evaluation of low-dose rtPA and early intensive blood pressure (BP) lowering in acute ischaemic stroke

Background: Controversy exists over the optimal dose (0.6 vs 0.9 mg/kg) of i.v. rtPA and control of elevated BP in acute ischaemic stroke. Asian studies suggest low dose rtPA is efficacious, while hypertension (>140 mmHg systolic) ‘before’ and ‘after’ rtPA predicts poor outcomes. Aims: ENCHANTED will assess in rtPA-eligible patients whether: (i) 0.6 mg/kg rtPA provides equivalent benefits and lower risk of major intracerebral haemorrhage (ICH) to 0.9 mg/kg rtPA; and (ii) early intensive BP lowering (target systolic 140-150 mmHg) provides superior benefits and lower ICH risk to BP guideline recommendations (systolic <180-185 mmHg). Methods: An independent, quasi-factorial, active-comparative, prospective, randomised, open blinded endpoint (PROBE), clinical trial evaluating [a] ‘rtPA dose’ and/or [b] ‘BP control’, using central internet randomisation of patients fulfilling local criteria for rtPA and uncertainty over the study treatments. Following a launch in late 2011, the study will expand across a global network (120+ sites) to achieve the required sample size of 5000 (3300 per treatment arm) to provide >90% power to detect non-inferiority of low-dose rtPA and superiority of intensive BP lowering. The study is funded by the Australian government (NHMRC project grant 1020462). Results: Following study in March 2012, 22 patients have been randomised from 10 active sites in Australia, China and Chile. Roll-out of ethics applications continues in the UK, Europe, Australasia and South America. Conclusions: Low-dose rtPA and early intensive BP lowering could provide more affordable and safer thrombolysis treatment of ischaemic stroke worldwide.

Graphic/Table:  
 

Presenting Author
C.S.  Anderson  
The George Institute for Global Health 
Sydney  
AUSTRALIA

Trialist:  

Co- Authors 2-15:
 V.  Sharma
National University of Hospital   Singapore   SINGAPORE

Y.  Huang
Peking Unversity First Hospita   Beijing   CHINA

P. Lavados
Clinica Alemana   Santiago   CHILE

 S.  Fuentes
The George Institute for Global Health   Sydney   AUSTRALIA

 N.H. Thang
 115 Hospital   Ho Chi Minh     VIETNAM

J.  Pandian
Christian Medical College   Ludiana   INDIA

R.  Lindley
The George Institute for Global Health  Sydney   AUSTRALIA

 C.  Stapf
Lariboisiere Hospital   Paris   FRANCE

 H.  Arima
The George Institute for Global Health   Sydney   AUSTRALIA

M. Parsons
John Hunter Hospital    Newcastle   AUSTRALIA

 C. Levi
John Hunter Hospital   Newcastle   AUSTRALIA

 T. Robinson
 University of Leicester    Leicester   UNITED KINGDOM

 J.S.  Kim
Asan Medical Center    Seoul   SOUTH KOREA

T. Lee
Chang Gung Memorial Hospital    Taipei   TAIWAN

OAID 51

Subject area/topic: Ongoing Trial

The second, main phase, of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2): progress update

Background: INTERACT2 is an open, randomised, blind end-point, multicentre clinical trial to establish the effectiveness of early intensive blood pressure (BP) lowering treatment in acute intracerebral haemorrhage (ICH), the most serious and least treatable form of stroke. Methods: A total of 2800 ICH patients with elevated systolic BP (150-220 mmHg) and capacity to receive intensive BP lowering treatment <6 hours of onset are required to be included from ~140 sites worldwide. Simple electronic data collection procedures are used and patients are centrally randomly assigned to intensive (target systolic <140 mmHg) or conservative (target systolic <180 mmHg) BP management using routine intravenous agents. Vital status and disability is assessed at 28 and 90 days. CT digital images are analysed centrally and there is central and site monitoring of data quality. The trial is registered (ACTRN1260800036239, NCT00716079, ISRCTN73916115). Results: Since study launch in October 2008, 2747 patients have been randomised from 120+ sites worldwide at the time of writing. Blinded data indicates adequate BP separation between randomised groups and primary 90-day event rates as expected. The required sample size will be achieved in June/July, and end of follow-up and close-out of sites completed in December 2012. Joint publication/presentation of the main results is planned for ESC 2013. Conclusions: INTERACT2 is on schedule to achieve its goals and establish any beneficial effects of early, more intensive, blood pressure control in ICH.

Graphic/Table:  
 

Presenting Author
C.S.  Anderson  
The George Institute for Global Health 
Sydney  
AUSTRALIA

Trialist:  

Co- Authors 2-15:
 Y.  Huang
Peking University First Hospital   Beijing   CHINA

J.  Wang
Rui Jin Hospital   Shanghai   CHINA

E. Heeley
The George Institute for Global Health   Sydney   AUSTRALIA

 C.  Delcourt
The George Institute for Global Health   Sydney   AUSTRALIA

 R. Lindley
 The George Institute for Global Health   Sydney    AUSTRALIA

H.  Arima
The George Institute for Global Health   Sydney   AUSTRALIA

T.  Robinson
University of Leicester  Leicester   UNITED KINGDOM

 P.  Lavados
Clinica Alemana   Santiago   CHILE

 M.  Parsons
John Hunter Hospital   Newcastle   AUSTRALIA

B. Neal
The George Institute for Global Health    Sydney   AUSTRALIA

 J. Chalmers
The George Institute for Global Health   Sydney   AUSTRALIA

OAID 54

Subject area/topic: Ongoing Trial

The DEDEMAS – (Determinants of Dementia after Stroke) Study: Study Design and Baseline Results

Backround: Vascular pathology is the second most common cause of dementia following Alzheimer’s disease. About 20% of patients with stroke become demented as an immediate consequence of their acute event but the mechanisms and determinants of post stroke dementia (PSD) are insufficiently understood. Methods: DEDEMAS is an observational prospective study in patients with acute stroke and no prior dementia. 600 subjects will be investigated by detailed interview (demographical data, medication, vascular risk factors), standardized clinical examinations (NIHSS, mRS), biometric measures (intima-media-thickness, waist-hip ratio, ankle-brachial index), multimodal imaging (MRI, FDG-PET, amyloid-PET, retinal imaging, sonography), analysis of blood and CSF including biobanking and detailed cognitive testing at repeat time points. Patients will be followed for 5 years with a total of 5 personal visits and 3 telephone interviews in between. Primary endpoint is the occurrence of PSD. Secondary endpoints include post stroke cognitive impairment no dementia (PSCI-ND) as well as secondary improvement of cognitive function. Predictive factors for PSD will be identified by multiple Cox-proportional hazards models and a risk score for PSD / PSCI-ND will be derived. Results: Between 05/2011 and 03/2012 we enrolled 51 patients. Baseline characteristics are as follows: median [Q1-Q3] age: 70 years [65-73], 19 (37%) were female. Median NIHSS at admission: 2 [1-5]; etiological stroke subtypes (modified TOAST classification): 13% large artery disease, 15% small vessel disease, 27% cardio-embolic, and 44% undetermined or multiple competing etiologies. Conclusion This study holds the potential to identify novel diagnostic markers and targets for preventive therapies of PSD (The study is registered at clinicaltrials.gov.; NCT01334749).

Graphic/Table:  
 

Presenting Author
FA  Wollenweber  
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University  
Munich  
GERMANY

Trialist:  

Co- Authors 2-15:
 V.D.  Zietemann
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

M.  Duering
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

C. Fuchs
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

 N.  Zieren
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

 A. Rominger
 Department of Nuclear medicine, Ludwig-Maximilians-University    Munich    GERMANY

B.  Ertl-Wagner
Department of Clinical Radiology, Ludwig-Maximilians-University    Munich   GERMANY

A.  Ossig
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University   Munich   GERMANY

 T.  Hasselwander
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

 A.  Doerr
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

A. Zollver
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University     Munich   GERMANY

 C Opherk
Institute for Stroke and Dementia Research, Ludwig-Maximilians-University    Munich   GERMANY

 M. Dichgans
 Institute for Stroke and Dementia Research, Ludwig-Maximilians-University     Munich   GERMANY

     
        

OAID 55

Subject area/topic: Ongoing Trial

Thrombolysis Or Anticoagulation for Cerebral venous Thrombosis (TO-ACT Trial)

Background Endovascular thrombolysis (ET), with or without mechanical clot removal, may be beneficial for a subgroup of patients with cerebral venous sinus thrombosis (CVT), who have a poor prognosis despite treatment with heparin. Published experience with ET is promising, but only based on case series. Objective The objective of the TO-ACT trial is to determine if ET improves the functional outcome of patients with a severe form of CVT. Methods The TO-ACT trial is a multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Patients are eligible if they have a radiologically proven CVT, a high risk of poor outcome (defined by presence of one or more of the following: mental status disorder, coma, intracranial hemorrhagic lesion, or thrombosis of the deep cerebral venous system) and if the responsible physician is uncertain whether ET or standard treatment is better. 164 patients will be included. Intervention Patients are randomized to receive either ET or standard treatment (therapeutic doses of heparin). ET consists of local application of rt-PA or urokinase within the thrombosed sinuses. Mechanical clot removal, such as thrombosuction, is allowed, but not mandatory. Outcomes The primary endpoint is the modified Rankin score (mRS) at 12 months, with a score ≥2 defined as poor outcome. Secondary outcomes are 6 months mRS, mortality and recanalization rate. Principal safety outcomes are major intra- and extracranial hemorrhagic complications. Results will be analyzed according to the "intention-to-treat" principle. Blinded assessors not involved in the treatment of the patient will assess endpoints with standardized questionnaires. Further information Trial started April 2011. Investigators who are interested and would like to participate please e-mail us at to-act@amc.nl

Graphic/Table: http://www.eurostroke.eu/OAID_55.html  
 

Presenting Author
J.M.  Coutinho  
Academic Medical Centre 
Amsterdam  
THE NETHERLANDS

Trialist: TO-ACT Investigator Collaboration

Co- Authors 2-15:
 J.M.  Ferro
Hospital Santa Maria   Lisbon   PORTUGAL

S.M.  Zuurbier
Academic Medical Centre   Amsterdam   THE NETHERLANDS

M. Mink
Academic Medical Centre   Amsterdam   THE NETHERLANDS

 P.  Canhão
Hospital Santa Maria   Lisbon   PORTUGAL

 I. Crassard
 Hôpital Lariboisière   Paris    FRANCE

C.B.  Majoie
Academic Medical Centre   Amsterdam   THE NETHERLANDS

J.A.  Reekers
Academic Medical Centre  Amsterdam   THE NETHERLANDS

 E.  Houdart
Hôpital Lariboisière   Paris   FRANCE

 R.J.  de Haan
Academic Medical Centre   Amsterdam   THE NETHERLANDS

M.G. Bousser
Hôpital Lariboisière    Paris   FRANCE

 J. Stam
Academic Medical Centre    Amsterdam   THE NETHERLANDS

OAID 56

Subject area/topic: Ongoing Trial

Study protocol of the Restore4Stroke self-management study: A multicentre randomized controlled trail in stroke patients and their partners.

Background: After being discharged home, many stroke patients and their partners report long-term negative consequences on health related quality of life. Adequate self-management abilities are essential in dealing with the stroke consequences, and interventions aimed at teaching these abilities seem to be appropriate. Aim: This study investigates the clinical effectiveness of a group intervention addressed at proactive self management strategies (SMI) compared to a group education intervention (EI) in stroke patients and partners. Design: During this multi-centre randomized controlled trial, at least 106 stroke patients and their partners will be randomly assigned to the 10-week SMI or EI within each of the ten participating hospitals and rehabilitation centres. Stroke patients’ main inclusion criteria are a symptomatic stroke at least six weeks ago and living at home, reporting at least two participation restrictions on the Utrecht Scale for Evaluation of Rehabilitation-Participation’s restriction scale (USER-P). Outcomes: Outcome is measured at baseline (T0), immediately after treatment (T1), 3 months (T2) and 9 months post treatment (T3). Primary outcomes are stroke patients’ and partners’ proactive coping competencies (Utrecht Proactive Coping Competence List) and societal participation (USER-P). Discussion: If effective, this study will enable stroke patients and their partners to deal with the lasting consequences of stroke better. In the view of the growing number of people returning home after stroke, a large number of people may profit form this intervention.

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Presenting Author
J.M.A.  Visser-Meily  
Rudolf Magnus Institute of Neuroscience and Center of Excellence for Rehabilitation Medicine  
Utrecht  
THE NETHERLANDS

Trialist: NTR3051

Co- Authors 2-15:
 N.S.  Tielemans
School for Mental Health and Neuroscience, Maastricht University Medical Centre    Maastricht   THE NETHERLANDS

V.P.M.  Schepers
Rudolf Magnus Institute of Neuroscience and Center of Excellence for Rehabilitation Medicine    Utrecht   THE NETHERLANDS

C.M. van Heugten
School for Mental Health and Neuroscience, Maastricht University Medical Centre    Maastricht   THE NETHERLANDS

OAID 57

Subject area/topic: Ongoing Trial

EuroHYP-1: European multicentre, randomised, phase III, clinical trial of hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

Background. In animal studies modelling ischaemic stroke, cooling to 35˚C reduced infarct size by about one third, and cooling to 34°C by around 45%. In clinical trials, cooling improved outcome in patients with hypoxic-ischaemic brain injury. For these reasons, hypothermia is the most promising treatment for patients with acute ischaemic stroke. Cooling awake patients with ischaemic stroke to 35°C has been shown feasible and safe, but whether this improves functional outcome has not yet been tested in an adequately-sized randomised clinical trial. Objective. To determine whether systemic cooling to a target temperature of 34 to 35°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke. Study design. Open, randomised, phase III, multicentre, international clinical trial with masked outcome assessment. Study population. 1500 patients aged 18 years or older with acute ischaemic stroke and a score on the National Institutes of Health Stroke Scale (NIHSS) of 6 up to and including 18, in whom there is a possibility to initiate cooling within 6 hours of symptom onset. Intervention. In patients randomised to hypothermia, cooling to a target rectal or bladder temperature of 34 to 35°C will be started within 6 hours after onset of symptoms and within 90 minutes of start of thrombolysis (or within 90 minutes of hospital admission in patients who are not treated with thrombolysis) with intravenous infusion of 20 ml/kg refrigerated normal saline (4°C). Cooling will be maintained for 24 hours with a surface or endovascular technique. Primary outcome measures. The common odds ratio of improvement on the modified Rankin Scale (mRS) at 90 days, as analysed with multiple ordinal logistic regression (shift analysis). Funding: 7th Framework Programme (FP7), EU (278709); W. Hacke (in pre-funding phase); Dutch Heart Foundation (to HBvdW).

Graphic/Table:  
 

Presenting Author
H.B.  van der Worp  
University Medical Centre Utrecht 
Utrecht  
THE NETHERLANDS

Trialist: EuroHYP-1 investigators

Co- Authors 2-15:
 R.  Kollmar
University of Erlangen   Erlangen   GERMANY

D.W.  Krieger
Copenhagen University Hospital Bispebjerg   Copenhagen   DENMARK

M.R. Macleod
University of Edinburgh   Edinburgh   UNITED KINGDOM

 J.  Petersson
Skane University Hospital   Malmo   SWEDEN

 I. Szabo
 European Stroke Research Network for Hypothermia   Brussels    BELGIUM

S.  Schwab
University of Erlangen   Erlangen   GERMANY

OAID 58

Subject area/topic: Ongoing Trial

The INTERnational Study on Primary Angiitis of the CEntral nervous system (INTERSPACE): take part in our international effort that is LAUNCHED TODAY

BACKGROUND: Current knowledge on primary angiitis of the CNS (PACNS) derives mostly from single-centre or retrospective studies with short duration follow-up. Predictors of outcome remain unknown for PACNS. OBJECTIVES: To identify predictors of death or dependence (mRS = 3 or more) at the end of follow-up (primary objective) and at 1 year following initiation of immunosuppressive therapy, to determine predictors of neurological deterioration due to treatment failure or recurrent PACNS, and to describe recognizable subsets of PACNS with different outcomes. METHODS: Patients aged 16 and older with: (a) an acquired neurological dysfunction (headaches, cognitive decline, seizures, or focal neurological deficit) consistent with PACNS, (b) a high-probability imaging study of the CNS vessels or CNS histopathology confirming PACNS, (c) brain (or spinal cord) MRI obtained before initiation of immunosuppressive therapy, (d) investigation results excluding PACNS mimickers, and (e) immunosuppressive therapy initiated 30 days or less before study enrolment, are eligible to INTERSPACE. Using electronic case report forms available at www.youngstrokenetwork.org, data of the 200 study participants will be collected at baseline (14th day following initiation of immunosuppressive therapy), neurological deteriorations, and pre-planned follow-up visits at 3, 6, 12 months, and at each additional year thereafter. Neurological deterioration is defined by the combination of specified clinical manifestations and investigation results consistent with active vasculitis more than 14 days after initiation of immunosuppressive therapy. MRI studies and CNS histopathological materials obtained from study participants will be blindly analyzed centrally, using standard criteria. Diagnosis and outcome events will be adjudicated. CONCLUSION: Assuming death or dependence in 30% of study participants at the end of follow-up, INTERSPACE will identify 6 predictors. Contact information: sylanthier@gmail.com

Graphic/Table:  
 

Presenting Author
V.  Dubuc  
Université de Montréal - CHUM 
Montreal  
CANADA

Trialist: The INTERSPACE Investigators

Co- Authors 2-15:
 L.C.  Gioia
Université de Montréal - CHUM   Montreal   CANADA

L.H.  Calabrese
Cleveland Clinic   Cleveland   USA

J.M. Ferro
Hospital Santa-Maria   Lisbon   PORTUGAL

 J.  Putaala
Helsinki University Central Hospital   Helsinki   FINLAND

 A.Y. Poppe
 Université de Montréal - CHUM   Montreal    CANADA

M.  Frosch
Massachusetts General Hospital   Boston   USA

J.  Raymond
Université de Montréal - CHUM  Montreal   CANADA

 F.  Guilbert
Université de Montréal - CHUM   Montreal   CANADA

 S.  Lanthier (Principal Investigator)
Université de Montréal   Montreal   CANADA

D. Strbian
Helsinki University Central Hospital    Helsinki   FINLAND

OAID 59

Subject area/topic: Ongoing Trial

PATCH Study: Platelet Transfusion in Cerebral Haemorrhage

Background Hematoma volume is one of the most important outcome predictors in intracerebral hemorrhage (ICH). At least 38% of patients suffer from hematoma growth which occurs mainly in the first 6 hours. If patients are selected carefully, outcome may be improved by limiting hematoma growth. The use of antiplatelet treatment (APT) seems to be a risk factor for the development of hematoma growth as well as poor outcome. Objective To investigate whether platelet transfusion in patients with ICH, who are using antiplatelet agents, improves outcome by preventing hematoma growth. Design PROBE design: Prospective, Randomized, Open treatment, Blinded Endpoint evaluation Inclusion criteria - Age  18 years - Spontaneous, non-traumatic supratentorial ICH confirmed by CT scan - GCS score 8-15 - Antiplatelet treatment in the week preceding ICH - Treatment can start  6 hrs after onset of symptoms - Treatment can start  1½ hrs after CT - Pre-stroke mRS score 0 or 1 Exclusion criteria - Suspected epidural, subdural, aneurysmal or AVM hematoma - Surgical evacuation planned  24 hrs - Intraventricular extension - Previous transfusion reaction - Use of Vitamin K antagonists (Warfarin) in the previous 5 days - Known thrombocytopenia < 100 x 109 /l - History of coagulopathy - Previously legally incompetence - Death appears imminent Sample size Outcome is assessed with the mRS, a score of 4 or more is defined as poor outcome. If poor outcome is reduced from 0.70 to 0.50, 95 patients are required in each group, totalling 190 patients. Outcome measure Primary outcome Poor outcome mRS 4-6 at 3 months Main secondary outcome - Hematoma growth  24 hrs - Complications of platelet transfusion (thrombotic complications and transfusion reaction) - Predictive value of the CTA "spot sign" regarding primary outcome - Predictive value of the CTA "spot sign" regarding hematoma growth - Patient’s functional health using the full ordinal scoring range of the mRS at 3 months

Graphic/Table:  
 

Presenting Author
K.  de Gans  
Groene Harts Ziekenhuis 
Gouda  
THE NETHERLANDS

Trialist:  

Co- Authors 2-15:
 M.  Vermeulen
AMC   Amsterdam   THE NETHERLANDS

Y.B.  Roos
AMC   Amsterdam   THE NETHERLANDS

OAID 60

Subject area/topic: Ongoing Trial

The Sleep Apnea cardioVascular Endpoints (SAVE) study: 1600 patients recruited

Background Despite increasing evidence of a link between obstructive sleep apnea (OSA) and cardiovascular (CV) disease, well powered randomised controlled trials (RCT) of OSA therapy focussed on hard CV endpoints are lacking. Methods SAVE is an international, multicentre RCT of CPAP therapy plus standard care versus standard care alone in 5000 patients with established CV disease and co-existing moderate-severe OSA to be followed-up over several years. Patients with a history of coronary artery disease or stroke/TIA who screen positive for OSA using a home monitoring device (Apnealink), are randomised following their satisfactory completion of a 1-week run-in phase of unblinded sham-CPAP. Results To date, over 1600 patients (286 Australia/NZ, 1244 China, and 78 India, 8 Spain, 2 USA) have been recruited from 75 sites. On average, 2-3 patients are screened for OSA for 1 patient to be randomised. Half (54%) of patients have a history of a stroke/TIA. CPAP adherence at 6 and 24 months is high, at 4.0+0.10 (n=563) and 4.0+0.19 (n=141) hours/night, respectively. The clinical network is currently being expanded to the United Kingdom and Brazil. Conclusions There has been widespread acceptance of the need for the SAVE trial by clinicians. Recruitment is increasing and CPAP adherence is high, reassuring us of the feasibility and quality of the study. TRIAL CONTACT INFORMATION: Global Study Director Dr Emma Heeley info@savetrial.org ph +61299934561. http://www.savetrial.org

Graphic/Table:  
 

Presenting Author
E.  Heeley  
The George Institute for Global Health, University of Sydney 
Sydney  
AUSTRALIA

Trialist: The SAVE Investigators

Co- Authors 2-15:
 C.  Anderson
The George Institute for Global Health, University of Sydney   Sydney   AUSTRALIA

N.  Antic
Adelaide Institute for Sleep Health, Flinders University, Adelaide, Australia   Adelaide   AUSTRALIA

Y Huang
Department of Neurology, Peking First University Hospital, Beijing, China.    Beijing   CHINA

 S.  Huang
Respiratory Medicine, Ruijin Hospital, Shanghai, China      

 J . Wang
 Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai, China       

N.  Zhong
Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical College, Guangzhou, China       

D.  McEvoy
Adelaide Institute for Sleep Health, Flinders University, Adelaide, Australia     

OAID 61

Subject area/topic: Ongoing Trial

THE URICOICTUS STUDY. A phase 3 study of Combined Treatment With Uric Acid and rtPA Administered Intravenously in Acute Ischemic Stroke Patients Within the First 4.5 Hours of Symptoms Onset

Background: Oxidative stress is a major contributor to brain damage in patients with ischemic stroke. Uric acid (UA) is a potent endogenous antioxidant molecule. In experimental ischemia in rats, the exogenous administration of UA is neuroprotective and enhances the effect of rt-PA. Moreover, in acute stroke patients receiving rtPA within 3 hours of stroke onset the intravenous administration of UA is safe, prevents an early fall in UA levels and reduces an early increase in oxidative stress markers and in matrix degrading enzymes (MMP9) levels. Purpose of the study: To determine whether the combined treatment with UA and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke patients treated within the first 4.5 hours of symptoms onset. Study design: Multicenter, interventional, randomized, double blind, vehicle controlled, efficacy study with parallel assignment (1:1). Estimated enrollment: 420 patients over 2 years. The study started at June 2011 and a total of 189 patients have been recruited (last update 09/May/2012). Treatment arms: Included patients will receive a single intravenous infusion of 1 gram of UA dissolved in a vehicle (500 ml of 0'1% Lithium Carbonate and 5% Mannitol) (n=210), or vehicle alone (n=210). Inclusion and exclusion criteria: The study will include patients older than 18 years old, treated with rtPA within the first 4.5 hours of clinical onset and with a baseline NIHSS>6 and <25 and a mRS score <=2 prior to the ischemic event. Patients with renal insufficiency, gout or asymptomatic hiperuricemia treated with allopurinol will be excluded. Outcome measures: The primary outcome measure is the proportion of patients achieving a mRS of 0 to 1 at 3 months after treatment, or 2 in those patients with a prior qualifying mRS of 2. Secondary outcome measures include final infarction volume measured at 72 hours and the proportion of patients with symptomatic intracranial hemorrhage (≥4 points increase in NIHSS score). Preplanned neuroimaging and blood biomarker substudies will also quantify signs of the biological activity of UA infusion using several validated surrogate outcomes.

Graphic/Table:  
 

Presenting Author
S.  Amaro  
Hospital Clínic de Barcelona 
Barcelona  
SPAIN

Trialist: On behalf of the URICOICTUS trial investigators

Co- Authors 2-15:
 M.  Castellanos
Hospital Universitari Doctor Josep Trueta   Girona   SPAIN

J.  Martí-Fàbregas
Hospital de la Santa Creu i Sant Pau   Barcelona   SPAIN

J.F. Arenillas
Hospital Clínico Universitario de Valladolid   Valladolid   SPAIN

 T.  Segura
Complejo Hospitalario Universitario de Albacete   Albacete   SPAIN

 J. Krupinski
 Hospital Mútua Terrassa   Terrassa    SPAIN

J.  Gállego
Complejo Hospitalario Pamplona   Pamplona   SPAIN

D.  Cánovas
Hospital Parc Taulí  Sabadell   SPAIN

 M.  Gomis
Hospital Universitari Germans Trias i Pujol   Badalona   SPAIN

 P.  Cardona
Hospital Universitari de Bellvitge   Barcelona   SPAIN

A. Chamorro
Hospital Clínic de Barcelona    Barcelona   SPAIN

OAID 62

Subject area/topic: Ongoing Trial

Development of training in psychological support after stroke for health professionals

Introduction The European Stroke Organisation concluded that psychological problems are common post-stroke and under diagnosed, but psychological interventions can elevate mood. This has also been recognised in the UK. Furthermore, the 2010 National Audit Office report of UK stroke services highlighted the widespread lack of provision of psychological care. A stepped approach to psychological care is recommended by NICE: starting with low level (step 1) interventions, moving to more complex (step 4) if required. Patients tend to discuss emotional issues with staff they spend most time with, so all staff need to be comfortable discussing psychological distress. Many staff report discomfort or lack confidence in this matter. This study aims to develop training on routine low level psychological support, deliverable by all staff. Focus groups recommended that training should be online and supported by face-to-face workshops to practice skills. Methods We requested materials from organisations that provide training in psychological support. The materials were matched to the competences in the Stroke-Specific Education Framework and developed into an online course supported by digital resources and assessments. Online training includes recognition, screening and management of psychological distress with a section on communicating with people with aphasia. Workshops were designed to enhance communication skills and provide staff with the competence to provide low level psychological care: active listening, normalising patients’ issues, and signposting other help. The training will be endorsed (UK Stroke Forum Education and Training) and will be applicable across the EU. Evaluation Implementation will be evaluated by changes in knowledge of post-stroke psychological issues and confidence in identifying and managing psychological distress. Our goal is to increase the number of patients who receive appropriate psychological support, and reduce psychological distress post-stroke.

Graphic/Table:  
 

Presenting Author
C.E.  Lightbody  
University of Central Lancashire 
Preston  
UNITED KINGDOM

Trialist: HIEC stroke theme

Co- Authors 2-15:
 M.A.  Auton
University of Central Lancashire   Preston   UNITED KINGDOM

K.  Patel
University of Central Lancashire   Preston   UNITED KINGDOM

H. Duff
Southport and Ormskirk NHS Hospital Trust   Southport   UNITED KINGDOM

 J.  Smith
Cheshire and Merseyside Cardiac and Stroke Network   Wirral   UNITED KINGDOM

 B. Simm
 Southport and Ormskirk NHS Hospital Trust   Southport    UNITED KINGDOM

L.  Connell
University of Central Lancashire   Preston   UNITED KINGDOM

J.  Vaughan
Cheshire and Merseyside Cardiac and Stroke Network  Wirral   UNITED KINGDOM

 M.J.  Leathley
University of Central Lancashire   Preston   UNITED KINGDOM

 C.L.  Watkins
University of Central Lancashire   Preston   UNITED KINGDOM

OAID 63

Subject area/topic: Ongoing Trial

Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome (SECRETO)

Background: Despite modern brain and vascular imaging and vast range of ancillary testing, etiology remains cryptogenic in at least 30-40% of ischemic strokes in patients aged <50 years. Design and Methods: The Searching for Explanations for Cryptogenic Stroke in the Young – Revealing the Etiology, Triggers, and Outcome (SECRETO) is an international prospective multicenter case-control study of young adults (age 18-49) presenting with an imaging-positive first-ever ischemic stroke of undetermined etiology (aim N=2000). Patients are included after standardized diagnostic procedures (brain MRI, MRA of intracranial and extracranial vessels, cardiac imaging, and screening for coagulopathies) and age- and sex-matched to healthy controls. Investigational blood and urine samples will be drawn at the time of recruitment and at 3-month follow-up visit. Further annual follow-up will be conducted by telephone or in person up to 10 years. SECRETO involves four principal aims: (1) To decipher stroke triggers and clinical risk factors; (2) Evaluate long-term prognosis (new vascular events, functional and psychosocial outcomes); (3) To analyze abnormalities of thrombosis and hemostasis; (4) To use genome-wide association study and next-generation sequencing to reveal novel pathways associated with young-onset arterial thrombosis. Furthermore, SECRETO substudies aim at collecting extensive family history of thrombotic events from informative patients and collect genetic samples from all consenting family members, and assessing the role of minor or subclinical atherosclerosis as well as finding new biomarkers reflecting different biological mechanisms associated with cryptogenic ischemic stroke at young age. Conclusions: SECRETO will provide novel information on clinical and subclinical risk factors, both transient and chronic, predisposing to cryptogenic ischemic stroke in young adults. Moreover, this study reveals long-term prognosis of this understudied patient population. JOIN SECRETO: jukka.putaala@hus.fi

Graphic/Table:  
 

Presenting Author
J.  Putaala  
Helsinki University Central Hospital 
Helsinki  
FINLAND

Trialist: For the SECRETO investigators.

Co- Authors 2-15:
 J.  Ferro
    Lisbon   PORTUGAL

S.  Kittner
    Baltimore   USA

S. Lanthier
    Montreal   CANADA

 U.  Waje-Andreassen
    Bergen   NORWAY

 F.-E. de Leeuw
     Nijmegen    THE NETHERLANDS

P.  Sharma
    London   UNITED KINGDOM

D.  Leys
   Lille   FRANCE

 B.  Siegerink
    Leiden   THE NETHERLANDS

 A.J.  Grau
    Ludwigshafen   GERMANY

V. Thijs
     Leuven   BELGIUM

 A. Algra
    Utrecht   THE NETHERLANDS

 F. Fazekas
      Graz   AUSTRIA

 H.  Naess
     Bergen   NORWAY

T. Tatlisumak
     Helsinki   FINLAND

OAID 64

Subject area/topic: Ongoing Trial

Vienna Interventional Management of Stroke Study (VIMS)

A prospective open-label clinical outcome and safety study of combined intravenous (IVT) and intra-arterial (IAT) administered rt-PA and mechanical thrombectomy in acute ischemic stroke Primary Objective: To compare clinical outcome of a combined IVT/IAT. approach to recanalisation with standard intravenous rt-PA alone as measured by modified Rankin Scale Score 0-2 after 3 months Overview of study design: The study will investigate endovascular therapy with rt-PA and/or thrombectomy in patients with proximal cerebral artery occlusions and severe clinical deficit (i.e. NIHSS ≥ 12), (preliminary) within a restricted time window (Monday to Friday, 08:00 a.m. to 1.00 p.m., due to the limited availability of an endovascular stroke team). Patients with acute ischemic stroke are routinely investigated clinically with CT or MRI and laboratory screening. If inclusion and exclusion criteria are fulfilled, endovascular therapy may be initiated either immediately after two-thirds of the standard IVT rt-PA dose has been given (´bridging´= local rt-PA and/or mechanical intervention) or later on after full standard dose IVT (´rescue`), if no clinical improvement (i.e. no recanalisation) has occurred. In the latter case, only mechanical intervention (thrombectomy) is applied. If there is a contraindication to IVT (e.g. postoperatively) IAT and/or mechanical intervention may be initiated in the first place (´primary endovascular treatment´). Baseline parameters and follow-up will be routinely investigated within the Austrian Stroke Unit Registry. Patients will have clinical study specific follow-up at 24 hours (NIHSS). Study specific documentation will be done at baseline, at the end of the interventional procedure (angiographic TIMI score, time to recanalisation), after 24 hours (NIHSS) and after 3 months (mRS).

Graphic/Table:  
 

Presenting Author
J.  Ferrari  
Neurological department,Hospital Barmherzige Brüder 
Vienna  
AUSTRIA

Trialist:  

Co- Authors 2-15:
 W.  Serles
Neurological department, Vienna Medical University    Vienna   AUSTRIA

W.  Lang
Neurological department,Hospital Barmherzige Brüder   Vienna   AUSTRIA

W. Grisold
Neurological department, Sozialmedizinisches Zentrum Süd   Vienna   AUSTRIA

OAID 65

Subject area/topic: Ongoing Trial

Outcomes in vitamin K antagonist-naïve and -experienced patients: results from ROCKET AF

Background: The ROCKET AF trial (N=14,264) showed that rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism (SE) among patients with atrial fibrillation (AF). We investigated whether the efficacy and safety of rivaroxaban compared with warfarin was consistent among vitamin K antagonist (VKA)-naïve and VKA-experienced patients. Methods: VKA experience was defined as the use of VKA therapy for at least 6 weeks before screening, and randomization was stratified by this variable. These analyses evaluated the interaction of the relative treatment effects of rivaroxaban and warfarin among VKA-naïve and VKA-experienced patients while on treatment. Event rates over the entire study period are presented per 100-patient years. Additionally, events from randomized study drug initiation through 30 days were evaluated. Results: Overall, 7897 (55.4%) patients were classified as VKA-experienced and 6367 (44.6%) were classified as VKA-naïve. VKA-experienced patients, compared with VKA-naïve patients, had a lower mean CHADS2 score (3.42 vs 3.53), were older (71.9 vs 70.4 years), and were more often male (73.0% vs 55.8%). The efficacy and safety outcomes are shown in the Table. In VKA-experienced patients, few strokes and SE events (rivaroxaban 6; warfarin 9) or major bleeding events (rivaroxaban 17; warfarin 15) occurred after study drug initiation through the first 30 days. Conclusion: In ROCKET AF, VKA-naïve patients have higher thromboembolic events rates compared with VKA-experienced patients. Efficacy and safety of rivaroxaban in both VKA-experienced and VKA-naïve patients are consistent with the primary trial results. A similar number of events occurred in the first 30 days after randomization in VKA-experienced patients assigned rivaroxaban or warfarin. These data support the safe transition of patients on VKA therapy to rivaroxaban once the international normalized ratio has fallen below 3.0.

Graphic/Table: http://www.eurostroke.eu/OAID_65.html
 

Presenting Author
K.W.  Mahaffey  
Duke Clinical Research Institute 
Durham  
USA

Trialist: ROCKET AF trialists

Co- Authors 2-15:
 D.  Wohdyla
       

G.J.  Hankey
        

H.D. White
       

 C.C.  Nessel
       

 J.P. Piccini
         

M.R.  Patel
       

R.C.  Becker
      

 J.L.  Halperin
       

 D.E.  Singer
       

S.D. Berkowitz
        

 R.M. Califf
       

 K.A.A. Fox
          

 G.  Breithardt
        

W. Hacke
        

OAID 66

Subject area/topic: Ongoing Trial

The assessment of the Plaque At RISK by non-invasive (molecular) imaging and modeling (ParisK): Prospective clinical study of the diagnosis of high risk plaque

Background The decision to perform a carotid endarterectomy (CEA) in patients with recent cerebrovascular symptoms is mainly based on degree of stenosis. Atherosclerotic disease in the carotid bifurcation and especially rupture of the plaque is a cause of ischemic stroke. We hypothesize that non-invasive imaging of the atherosclerotic plaque is capable to identify patients in the symptomatic 30-69% carotid artery stenosis group with an increased risk of recurrent stroke. Methods A prospective multicenter study has started in September 2010. We aim to include 300 patients with recent neurological symptoms due to ischemia in the territory of the carotid artery and a 30-69% ipsilateral carotid artery stenosis who are not scheduled for CEA or stenting. At baseline, multidetector computer tomography angiography (MDCTA), 3T magnetic resonance imaging (MRI) and ultrasound (US) of the carotid arteries are performed. In addition, MRI of the brain, ambulant transcranial doppler (TCD) of the middle cerebral artery for a period of 4 hours and blood withdrawal for biomarkers will be performed. After two years MDCTA, 3T MRI and US of the carotid artery and MRI of the brain will be repeated. Endpoint of the study is recurrent TIA or ischemic stroke or new ischemic brain lesions on MRI. Results Until March 2012, 78 patients have been included. Mean age of the patients was 69 (range 39-88), 72% was male, 53% of the patients had an ischemic stroke and 47% a TIA. Additional plaque imaging was performed on average 43 days (range 4-100) after the ischemic event. Patients will be included until the end of 2013. Final results are expected in 2015. Conclusion We aim to assess whether non-invasive imaging of the symptomatic carotid plaque will improve the selection of patients who would benefit of a carotid intervention. Acknowledgement This research was supported by the Center for Translational Molecular Medicine and the Dutch Heart Foundation (PARISk).

Graphic/Table:  
 

Presenting Author
A.C.  van Dijk  
Erasmus Medical Center 
Rotterdam  
THE NETHERLANDS

Trialist: ClinicalTrials.gov NCT01208025

Co- Authors 2-15:
 M.T.B.  Truijman
Maastricht University Medical Center   Maastricht   THE NETHERLANDS

A.G.  van der Kolk
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

A.A.J. de Rotte
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

 M.J.A.P.  Daemen
Academic Medical Center   Amsterdam   THE NETHERLANDS

 A.F.W. van der Steen
 Erasmus Medical Center   Rotterdam    THE NETHERLANDS

W.H.  Mess
Maastricht University Medical Center   Maastricht   THE NETHERLANDS

P.J.  Koudstaal
Erasmus Medical Center  Rotterdam   THE NETHERLANDS

 R.J.  van Oostenbrugge
Maastricht University Medical Center   Maastricht   THE NETHERLANDS

 H.B.  van der Worp
University Medical Center Utrecht   Utrecht   THE NETHERLANDS

A.J. Nederveen
Academic Medical Center    Amsterdam   THE NETHERLANDS

 P.J. Nederkoorn
Academic Medical Center   Amsterdam   THE NETHERLANDS

 J. Hendrikse
 University Medical Center Utrecht    Utrecht   THE NETHERLANDS

 M.E.  Kooi
Maastricht University Medical Center    Maastricht   THE NETHERLANDS

A. van der Lugt
Erasmus Medical Center    Rotterdam   THE NETHERLANDS

OAID 67

Subject area/topic: Ongoing Trial

A Common Data Language for Clinical Research Studies: The National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Elements (CDEs)

Background: To reduce study start-up time and accelerate data sharing, the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, convened a Working Group of experts to develop common data elements (CDEs) for adult and pediatric stroke clinical research studies. Version 1.0 of the Stroke CDEs was published on the NINDS CDE Web site (http://www.commondataelements.ninds.nih.gov/) in December 2010. The NINDS has undertaken various activities to encourage researchers to use the Stroke CDEs and to ensure they remain a current and useful resource for research. Methods: Promotional activities include: convening a Stroke CDE Oversight Committee to help maintain and improve the CDEs; publicizing the existence of the Stroke CDEs in NINDS program announcements, at conferences, and in journals; offering CDE Web site training via webinars, training sessions at meetings, and tutorials on the Web site; connecting newly funded investigators with the NINDS CDE Team to offer training and advice on how to incorporate the Stroke CDEs into their studies; and collecting feedback from researchers who are using the Stroke CDEs. Results: The poster presentation will convey the latest and most pertinent information about the Stroke CDEs including: examples of how the Stroke CDEs may be used by a research study; demonstrations of navigating the Web site and selecting CDEs from it; explanation of how to submit feedback on the CDEs; description of training available to research teams interested in using the CDEs; and updates on the Stroke CDE Oversight Committee, including discussions from their first meeting which took place during the 2012 International Stroke Conference. Conclusions: The NINDS is strongly encouraging investigators of Phase III and exploratory clinical trials to use the CDEs in their case report forms and data managements systems (refer to PAR-11-173 and PAR-10-199). Thus far, several NINDS-funded stroke trials have utilized the Stroke CDEs and the NINDS CDE Team is collecting feedback from those trials. This feedback is crucial as it will enable the Stroke CDE Oversight Committee to maintain and improve the Stroke CDEs over time.

Graphic/Table:  
 

Presenting Author
P.  Khatri  
University of Cincinnati 
Cincinnati  
USA

Trialist: NINDS Stroke CDE Oversight Committee

Co- Authors 2-15:
 J.  Saver
University of California, Los Angeles   Los Angeles   USA

S.  Warach
University of Texas Southwestern Medical Center   Dallas   USA

OAID 68

Subject area/topic: Ongoing Trial

The THERAPY Trial: A prospective, randomized, concurrent controlled trial to assess safety and effectiveness of the Penumbra System® as adjunctive treatment to IV rtPA in acute ischemic stroke

BACKGROUND: Recent evidence suggests that clot lengths of at least 8 mm in acute ischemic stroke patients may be refractory to recanalization by IV rtPA. These patients may therefore be better candidates for combined IV/IA therapies (Riedel et al, Stroke 2011;42:1775). The aim of the THERAPY Trial is to assess the safety and effectiveness of the Penumbra System® as adjunctive treatment to IV rtPA in this cohort of stroke patients with large vessel occlusions due to thrombi of 8mm or longer. METHODS: The THERAPY Trial is a prospective, multicenter, randomized, concurrent controlled, Phase III study. Eligible patients [n=582] are 18 to 85 years of age presenting with symptoms of acute ischemic stroke and an NIHSS score of > 8 or aphasic, who have evidence of a clot length ≥ 8mm in the anterior circulation in a proximal artery. They are randomized (1:1) to standard IV rtPA therapy alone or combined IV rtPA therapy and adjunctive endovascular treatment with the Penumbra System. The primary endpoints are good functional outcome (mRS 0-2) at 90 days and the incidence of serious adverse events. An independent Clinical Event Committee/Data Safety Monitoring Board will evaluate safety events and monitor safety for the trial. RESULTS: Approximately 40 centers have committed to the THERAPY to date in the United States, and 17 have received IRB approval. Currently, 10 centers are screening, and three patients are enrolled. CONCLUSIONS: The THERAPY trial should help clarify the role of IA mechanical thrombectomy as adjunctive therapy to IV rtPA treatment in improving clinical outcome after ischemic stroke. Given that the NIH-funded IMS III (with broader inclusion criteria) was recently halted for futility after enrolling 656 subjects, it becomes critical to study those most likely to benefit from adjunctive IA therapy in further Phase III, randomized trials.

Graphic/Table:  
 

Presenting Author
P.  Khatri  
University of Cincinnati 
Cincinnati  
USA

Trialist: The Penumbra THERAPY Trial Investigators

Co- Authors 2-15:
 J.  Mocco
Vanderbilt University   Nashville   USA

O.  Zaidat
Medical College of Wisconsin   Milwaukee   USA

OAID 69

Subject area/topic: Ongoing Trial

Neurological Routine Assessment in Preoperative and Postoperative of Coronary Artery Bypass Surgery

Coronary artery bypass grafting is an effective surgical therapy for coronary artery disease. In the past two decades, there have been significant changes in the population undergoing cardiac surgery. Improvements in surgical procedures have made it possible to operate successfully on older patients with more comorbid disease. Conversely, this population is at higher risk for age-related cerebrovascular disease, including stroke and encephalopathy, during the immediate postoperative period. Stroke (and encephalopathy) is one of the most devastating complications of cardiac surgery, causing poor functional outcomes and increased mortality, length of hospitalization, and need for long-term care. Primary Outcome Measure - Prevalence of stroke and encephalopathy after coronary artery bypass surgery. Secondary Outcome Measures - Disability after 90 days measured by modified Rankin Scale - Place where the patient will stay after hospital discharge. - Mortality rate - Days of hospitalization Design: retrospective and prospective cohort Participants: 200 patients (100 patients retrospective and 100 prospective) Inclusion - Patients undergoing exclusively to coronary artery bypass grafting. Exclusion - Age less than 18 years old - Moderate and severe disability previous (modified Rankim ≥ 3) Methodology We selected 100 consecutives and retrospectives patients undergone to coronary artery bypass graft with standard preoperative and postoperative care and registered prevalence of neurological complications and outcome. In the prospective phase, we will perform preoperative neurological assessment and the patients will be routinely evaluated by cervical and cerebral CT angiography and selected cases will be treated with endovascular or surgical techniques. All patients will receive also neurological evaluation in the first day of surgery to detect encephalopathy/stroke and began very early measures to stroke management

Graphic/Table:  
 

Presenting Author
A.A.  Maulaz  
Hospital São Francisco, Santa Casa de Porto Alegre 
Porto Alegre  
BRAZIL

Trialist:  

Co- Authors 2-15:
 L.A.  Jung
Hospital São Francisco, Santa Casa de Porto Alegre   Porto Alegre   BRAZIL

A.  Rösler
Hospital São Francisco, Santa Casa de Porto Alegre   Porto Alegre   BRAZIL

D. Fialho
Hospital São Francisco, Santa Casa de Porto Alegre   Porto Alegre   BRAZIL

 P.E.  Leães
Hospital São Francisco, Santa Casa de Porto Alegre   Porto Alegre   BRAZIL

 F.A. Lucchese
 Hospital São Francisco, Santa Casa de Porto Alegre   Porto Alegre    BRAZIL

OAID 70

Subject area/topic: Ongoing Trial

INTERnational Study on Primary Angiitis of the CEntral nervous system (INTERSPACE): preliminary feasibility study

BACKGROUND: INTERSPACE is an international, multicentre, prospective, observational database designed to identify predictors of dependence or death associated with primary angiitis of the central nervous system (PACNS). We hypothesized that an average of 0.5 PACNS patients will be recruited annually from each participating center. Because PACNS is a rare disease with variable clinical presentation, identification of cases in each participating centers may be challenging yet important for the feasibility of INTERSPACE and the generalizability of its results. OBJECTIVES: To verify the expected annual recruitment rate of PACNS patients (primary objective), to identify potential sources of recruitment, and to collect other relevant data for planning of INTERSPACE. METHODS: Reflecting the study population of INTERSPACE, inclusion criteria of the feasibility study are: (a) age 16 or older, (b) an acquired neurological dysfunction (headaches, cognitive decline, seizures, or focal neurological deficit) consistent with PACNS, (c) a high-probability imaging study of the CSN vessels consistent with PACNS or CNS histopathology confirming PACNS, (d) brain (or spinal cord) MRI obtained before initiation of immunosuppressive therapy, and investigation results excluding PACNS mimickers. In addition, the immunosuppressive therapy should have been initiated (or the diagnosis of PACNS established if not treated) no more than 5 years prior to recruitment. Eligible patients will be identified from a formal search of medical records, using ID-9 codes (or other classification systems) for isolated, granulomatous, or PACNS, or CNS vasculitis, and by questioning specialists typically involved in the care of PACNS patients, including rheumatologists, neurologists, internists, and pathologists. Minimal clinical data (e.g., diagnostic modalities, length of follow-up) will be collected on each case from chart review. CONCLUSION: A feasibility will help assess practicality, implementation, and generalizability of INTERSPACE.

Graphic/Table:  
 

Presenting Author
L.C.  Gioia  
CHUM - Université de Montréal 
Montreal  
CANADA

Trialist: The INTERSPACE Investigators

Co- Authors 2-15:
 V.  Dubuc
CHUM - Université de Montréal   Montreal   CANADA

G.  Jacquin
CHUM - Université de Montréal   Montreal   CANADA

J.M. Ferro
Hospital Santa Maria   Lisbon   PORTUGAL

 L.H.  Calabrese
Cleveland Clinic   Cleveland   USA

 J. Putaala
 Helsinki University Central Hospital   Helsinki    FINLAND

D.  Strbian
Helsinki University Central Hospital   Helsinki   FINLAND

A.Y.  Poppe
CHUM - Université de Montréal  Montreal   CANADA

 M.P.  Frosch
Massachusetts General Hospital   Boston   USA

 J.  Raymond
CHUM - Université de Montréal   Montreal   CANADA

F. Guilbert
CHUM - Université de Montréal    Montreal   CANADA

 S. Lanthier
CHUM - Université de Montréal   Montreal   CANADA

OAID 71

Subject area/topic: Ongoing Trial

Intensive vascular care to prevent dementia, stroke and handicap – the preDIVA cluster-randomised trial

Background Vascular risk factors including hypertension, DM, hypercholesterolemia, obesity and smoking are associated with an increased risk of dementia, stroke and other cardiovascular complications. Whether multi-component treatment targeting all risk factors can prevent dementia, stroke and other cardiovascular events is unclear. Methods The ‘Prevention of Dementia by Intensive Vascular Care’ (preDIVA) study is a cluster-randomised trial in subjects aged 70-78, started in 2006. The effect of a nurse-led multi-component pharmacological and non-pharmacological intervention targeting all vascular risk factors during 4-monthly visits is evaluated. Intervention and follow-up are 6 years. Primary outcomes are dementia and handicap. Main secondary outcomes are stroke, myocardial infarction and mortality. Results 3534 participants have been included. 9.9% (n=350) had a history of TIA/stroke; 35% had a history of any cardiovascular disease. At baseline only 13% had no vascular risk factor amenable to intervention. Systolic BP was >160 mmHg in 37%, of whom 52% was untreated. 25% had a BMI>30, 18% had DM, 13% smoked and 22% had a total cholesterol >6.5 mmol/l. Data-entry of 2200 subjects at 2-year follow-up has been completed recently. Mean decrease of systolic BP (intervention vs. control) was 7.9 mmHg vs. 3.4 mmHg (p<0 .01). Mean decrease of diastolic BP was 2.4 mmHg vs. 0.8 mmHg (p<0 .01). Abdominal circumference decreased 0.01 cm in the intervention group and increased 0.65 cm in the control group (p=0.04). There were no differences in total cholesterol, HDL or LDL. In late 2012 the first patients will complete the 6-year follow-up. Final results are expected in 2015. Discussion Preliminary analysis confirms that a multi-component intervention targeting all vascular risk factors in elderly subjects is feasible. Whether this will translate into reduction of incident dementia, stroke and other cardiovascular complications will become clear in the near future.

Graphic/Table:  
 

Presenting Author
E.  Richard  
Academic Medical Centre, University of Amsterdam, dept Neurology 
Amsterdam  
THE NETHERLANDS

Trialist:  

Co- Authors 2-15:
 E.P.  Moll van Charante
Academic Medical Centre, University of Amsterdam, dept General Practice   Amsterdam   THE NETHERLANDS

L.S.  Eurelings
Academic Medical Centre, University of Amsterdam, dept Neurology   Amsterdam   THE NETHERLANDS

S.A. Ligthart
Academic Medical Centre, University of Amsterdam, dept General Practice   Amsterdam   THE NETHERLANDS

 W.A.  van Gool, dept Neurology
Academic Medical Centre, University of Amsterdam   Amsterdam   THE NETHERLANDS

OAID 72

Subject area/topic: Ongoing Trial

Hyper-acute Stroke Research Centre Set-up by the NIHR Stroke Research Network

Introduction: In April 2010, the UK National Institute for Health Research (NIHR) Stroke Research Network (SRN) secured €1.2 Million per annum government funding for three years to develop up to eight English Hyper-acute Stroke Research Centres (HSRCs) to support the delivery of complex research studies in hyper-acute stroke (e.g. those requiring immediate advanced imaging and/or neuro-interventional facilities). Progress to date: After a competitive bidding process, eight HSRCs were established in Cambridge, London (Kings, St George’s, University College Hospitals) Newcastle, Nottingham, Salford and Stoke-on-Trent. All HSRCs have implemented out of hours medical and research nursing cover and diagnostic and interventional neuro-radiology provision to support hyper-acute research studies. There are currently eight studies , seven of which are randomised control trials and three of which are industry sponsored –(DIAS4, Talecris, SOS penumbra), open on the hyper-acute portfolio. Eleven more studies are seeking funding or in set-up. In 2009/10, the eight centres recruited a total of 54 stroke patients into hyper-acute studies and 383 patients into acute studies. After HSRC investment in 2010/11 the eight centres recruited a total of 126 stroke patients into hyper-acute studies (target 120) and 693 patients into acute studies (target 320). In 2011/12 the eight centres recruited a total of 119 stroke patients and 15 non-stroke patients into hyper-acute studies, 37 of whom required complex imaging based invention or diagnosis (target 120, individual centre range 0-46) and 843 patients into acute studies (target 320, individual centre range from 40-168 patients recruited. The lower figure for hyper-acute recruitment is due to the closure of the IST3 project in July 2011. Up until that time, hyper-acute recruitment was up an average of 266% each month compared to the monthly figures for 2010/11. Conclusions: Investment in hyper-acute stroke research infrastructure has increased research activity and established multidisciplinary hyper-acute research teams.

Graphic/Table:  
 

Presenting Author
A.  Majid  
Salford Royal Hospital 
Manchester  
UNITED KINGDOM

Trialist: HSRC collaborators and leads

Co- Authors 2-15:
 K.E.  Wilde
North Staffordshire Combined Healthcare Trust   Stoke-on-Trent   UNITED KINGDOM

P.M.W.  Bath
City Hospital Nottingham   Nottingham   UNITED KINGDOM

C. Roffe
University Hospital North Staffordshire   Stoke-on-Trent   UNITED KINGDOM

 E.  Warburton
Addenbrookes Hospital   Cambridge   UNITED KINGDOM

 R. Perry
 University College Hospital, London   London    UNITED KINGDOM

L.  Kalra
Kings College London   London   UNITED KINGDOM

B.  Moynihan
St Georges Hospital  London   UNITED KINGDOM

 A.  Dixit
Royal Victoria Infirmary   Newcastle upon Tyne   UNITED KINGDOM

 G.A.  Ford
Newcastle University   Newcastle upon Tyne   UNITED KINGDOM

K.R. Lees
University of Glasgow    Glasgow   UNITED KINGDOM

 K.W. Muir
University of Glasgow   Glasgow   UNITED KINGDOM

 P. White
 University of Edinburgh    Edinburgh   UNITED KINGDOM

     
        

OAID 73

Subject area/topic: Ongoing Trial

CROMIS-2: Microbleeds and genetic risk factors to predict the risk of intracranial haemorrhage in patients treated with anticoagulation following cardioembolic stroke due to atrial fibrillation.

Introduction: Over the last decade, increasing use of oral anticoagulants to prevent cardioembolic stroke due to atrial fibrillation (AF) in an ageing population has led to a five-fold increase in the incidence of anticoagulant-related intracranial haemorrhage (ICH)-a rare but unpredictable and catastrophic complication. Cerebral microbleeds (CMBs) on MRI may predict ICH risk, as may genetic polymorphisms influencing brain small-vessel integrity or anticoagulation stability. Aims and Methods: CROMIS-2 (Clinical Relevance Of Microbleeds In Stroke) aims to establish the value of CMBs and genetic factors in predicting symptomatic ICH following oral anticoagulation to prevent recurrent ischaemic stroke due to AF, by using two complementary designs. Study I (AF) is a prospective, multicentre, inception cohort study in 1000 patients with ischaemic stroke due to AF started on oral anticoagulation. Patients will have genetic testing and standardized MRI including GRE at baseline, with follow-up by postal questionnaires. We will compare the rate of symptomatic ICH between CMB and CMB-free patients and test for associations with plausible candidate genes. Study II (ICH) is an observational study of ICH investigating genetic, clinical and radiological risk factors associated with anticoagulant-related ICH. We will recruit 600 patients admitted with ICH (with a target of at least 300 anticoagulant-related ICH cases), building a UK-wide ICH registry. Expected Results: We aim to develop a predictive model for ICH risk after oral anticoagulation for AF, which will help to determine whether genetic or CMB screening should be used in clinical practice and future trials. New genetic, clinical and radiological risk factors associated with anticoagulant-related ICH will be identified. Study update: The CROMIS-2 study has been adopted by the NIHR UK Stroke Research Network. Recruitment commenced August 2011 and will continue over 36 months. There are currently 43 sites open to recruitment across the UK – a further 8 sites are due to open in May and June 2012. More centres are still welcome. 261 patients in total have now been recruited to CROMIS-2.

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Presenting Author
A.  Charidimou  
UCL Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG 
London  
UNITED KINGDOM

Trialist: Not a trial

Co- Authors 2-15:
 C.  Shakeshaft
UCL Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG   London   UNITED KINGDOM

D.J.  Werring
UCL Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG   London   UNITED KINGDOM

OAID 74

Subject area/topic: Ongoing Trial

ACTION ON SECONDARY PREVENTION INTERVENTIONS AND REHABILITATION IN STROKE – THE ASPIRE-S STUDY

Stroke is the third leading cause of death and the leading cause of adult disability in Europe. The forecasted growth in stroke incidence (and related costs), creates a need for improved treatment strategies for survivors. Secondary prevention and appropriate community rehabilitation improve long-term patient outcome and community burden from stroke. However, comprehensive information on adequacy of secondary prevention and rehabilitation for Irish patients is unavailable. ASPIRE-S will assess the secondary prevention and rehabilitation profile of patients six months following hospital admission for stroke, focusing on the three key dimensions of quality care; patient safety, effective care, patient experience. ASPIRE-S is funded by the Health Research Board of Ireland. Patients admitted with a diagnosis of ischaemic stroke to the three main North Dublin city hospitals - Beaumont, Connolly and the Mater Hospitals – are included. Recruitment began October 2011 and will continue for one year. At six months, a home assessment is completed, following the EUROASPIRE protocol for evaluation of secondary prevention in post-discharge cardiac patients. In addition, the researchers measure compliance with rehabilitation recommendations (defined at discharge) and ongoing rehabilitation need (in terms of mobility, cognitive and speech and language ability). To date 175 patients have been recruited. Mean age is 68 years (SD 13.1; range 21-96). The risk factor profile highlights hypertension as the most common risk factor (52%), followed by hypercholesterolaemia (39%), previous stroke (23%) and smoking (21%). Mean modified Rankin score and Barthel Index score at 72 hours post stroke are 2 and 15.8 respectively, indicating moderate level of disability. Hospital recruitment and follow-up assessments for ASPIRE-S are ongoing. The results from this study will give new insights into the adequacy of secondary prevention, rehabilitation needs and intervention six months post-stroke in Dublin. Results will inform future service needs and may determine where scarce resources can be targeted.

Graphic/Table: http://www.eurostroke.eu/OAID_74.html
 

Presenting Author
L.  Brewer  
Royal College of Surgeons in Ireland 
Dublin  
IRELAND

Trialist:  

Co- Authors 2-15:
 L.  Mellon
Royal College of Surgeons in Ireland   Dublin   IRELAND

P.  Hall
Royal College of Surgeons in Ireland   Dublin   IRELAND

A. Hickey
Royal College of Surgeons in Ireland   Dublin   IRELAND

 F.  Horgan
Royal College of Surgeons in Ireland   Dublin   IRELAND

 E. Shelley
 Royal College of Surgeons in Ireland   Dublin    IRELAND

H.  McGee
Royal College of Surgeons in Ireland   Dublin   IRELAND

P.  Kelly
Mater Misericordiae University Hospital  Dublin   IRELAND

 E.  Dolan
Connolly Hospital   Dublin   IRELAND

 S.  Murphy
Mater Misericordiae University Hospital   Dublin   IRELAND

J. Moroney
Beaumont Hospital    Dublin   IRELAND

 A . Moore
Beaumont Hospital   Dublin   IRELAND

 C. Donegan
 Beaumont Hospital    Dublin   IRELAND

 D.  Williams
Royal College of Surgeons in Ireland    Dublin   IRELAND

OAID 75

Subject area/topic: Ongoing Trial

Implementing Telemedicine in Acute Stroke

Introduction: Delivery of rapid intravenous thrombolysis can be facilitated by telemedicine. It is important to take account of organisational, staff, patients’ and carers’ perspectives in order to optimise the reliability and acceptability of telemedicine in the assessment of acute stroke patients. Research must highlight what makes telemedicine workable, as well as how it can improve the quality of care. We constructed a standardised toolkit for the implementation of telemedicine in the UK. This standardised telemedicine toolkit is currently being tested in practice and the consequences evaluated for professionals and patients. Method: The preliminary Standardised Toolkit was used in the real time assessment of suspected stroke patients. Subsequently, end users’ (patient, carer and health professional) views of its real time acceptability and feasibility are being explored through semi structured interviews to gain their perceptions of the: optimal mode of delivery of telemedicine assessment, including technical factors, patient characteristics, and knowledge and skills of clinical users. Interviews are transcribed verbatim and analysed using Normalisation Process Theory as a framework. Results: Initial findings from interviews with 6 health care staff (3 stroke physicians who are remote assessors; 3 bedside assessors) from 5 study sites suggest key challenges may include: concerns as to whether it can enable subtle factors in patient assessment to be elicited; standardisation of procedures across multiple sites; issues of trust, confidence and skill set variability between sites; and feedback on patient outcomes. Data collection is ongoing with staff, patients and carers to identify how the use of telestroke systems can be optimised. The findings will inform the further development of the online Standardised Telemedicine Toolkit (http://www.astute-telestroke.org.uk/ ).

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Presenting Author
C.E.  Lightbody  
University of Central Lancashire 
Preston  
UNITED KINGDOM

Trialist: ASTUTE

Co- Authors 2-15:
 J.M.E.  Gibson
University of Central Lancashire   Preston   UNITED KINGDOM

B.  French
University of Central Lancashire   Preston   UNITED KINGDOM

A. McLoughlin
University of Central Lancashire   Preston   UNITED KINGDOM

 J.  Fitzgerald
University of Central Lancashire   Preston   UNITED KINGDOM

 A. Gibson
 University of Central Lancashire   Preston    UNITED KINGDOM

J.J.  McAdam
University of Central Lancashire   Preston   UNITED KINGDOM

E.  Day
Cumbria and Lancashire Cardiac and Stroke Network      UNITED KINGDOM

 P.  Davies
North Cumbria University Hospitals NHS Trsut   Carlisle   UNITED KINGDOM

 H.  Emsley
Lancashire Teaching Hospitals NHS Trust   Preston   UNITED KINGDOM

G.A. Ford
University of Newcastle    Newcastle   UNITED KINGDOM

 C. Price
Northumbria Healthcare NHS Trust       UNITED KINGDOM

 C. May
 University of Southampton    Southampton   UNITED KINGDOM

 M.  O'Donnell
Blackpool Teaching Hospitals NHS Foundation Trust    Blackpool   UNITED KINGDOM

C.L. Watkins
University of Central Lancashire    Preston   UNITED KINGDOM

OAID 76

Subject area/topic: Ongoing Trial

Establishing the effects of Fluoxetine initiated in the acute phase of stroke – a highly promising new treatment. Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke (EFFECTS)

Background: More than half of stroke survivors are disabled after one year. New effective treatments are urgently needed. In animal and human studies, selective serotonin reuptake inhibitors (SSRIs) have shown potentially beneficial effects on both normal and diseased brain. Fluoxetine, a well studied SSRI, has in small clinical trials shown functional and deficit improvement and less frequent depression, quite remarkable in the FLAME trial, n=118, with 17% absolute difference in functional outcome (Chollet et al 2011). However, replication is needed; results must be confirmed or refuted in larger studies. Further, potential mechanisms of action need to be studied. Main research question: Does fluoxetine 20mg od during six months started within the acute phase improve functional outcome? Methods: EFFECTS is a prospective multicentre double blind trial. The primary outcome is the proportion of patients alive and independent by the mRS (0, 1, and 2) at 6 months. Secondary outcomes are: survival, recovery of deficits, vitality, sustainable effect at 12 months, depression, and health related quality of life. Randomisation is by a secure central web-interface to guard allocation concealment. Treatment-arms are balanced for key prognostic factors. At 6 months there is a local centre face-to-face follow-up. Central follow-ups are at six and 12 months by questionnaires, or telephone, from the main centre. EFFECTS aim at 1500 patients yielding 90% power to detect a 7.5% absolute difference at alpha 0.05. We work in collaboration with the British FOCUS, and the Australian AFFINITY, trials. Hence, generalisability can be assessed. Our shared minimal data set will allow pooling of data to detect benefits in specific subgroups as defined by deficits, stroke- type and location. Potential impact: If the clinical worth-while effect is confirmed, fluoxetine may well become either a standard medication in stroke, or directed to patient-groups identified as most likely to benefit.

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Presenting Author
E.  Lundström  
Neurology, Uppsala university 
Uppsala  
SWEDEN

Trialist: EFFECTS group

Co- Authors 2-15:
 B.  Norrving
Lund University   Lund   SWEDEN

P.  Wester
Umeå University   Umeå   SWEDEN

K. Stibrant Sunnerhagen
Gothenburg University   Gothenburg   SWEDEN

 B.  Mårtensson
Karolinska Institutet   Stockholm   SWEDEN

 A. von Heine
 Karolinska Institutet   Stockholm    SWEDEN

P.  Näsman
Karolinska Institutet   Stockholm   SWEDEN

N.  Zethraeus
Karolinska Institutet  Stockholm   SWEDEN

 E.  Isaksson
Karolinska Institutet   Stockholm   SWEDEN

 V.  Murray
Karolinska Institutet   Stockholm   SWEDEN

OAID 77

Subject area/topic: Ongoing Trial

STROKDEM Study Characterisation of factors influencing the onset of post-stroke dementia

Aim of the study: The aim of the STROKDEM Study is to identify the prognosis factors that positively or negatively influence the onset of dementia following strokes by the prospective follow-up of a group of patients having no dementia who have presented with a first stroke. The originality of the study is based on a systematic follow-up of the clinical, biological, imaging and pharmacological factors Methodology: The study is be based on the prospective five-year follow-up of a group of 1,100 patients with no dementia who have had a first stroke, caused by ischemia or a haemorrhage, in the supratentorial area, going back no less than 72 hours. Upon inclusion, background and risk factors, previous treatments, clinical (severity) and etiological (imaging, vascular and cardiac assessment) data of the stroke, as well as the blood samples to be used to test for the pertinent biomarkers (inflammation, haemostasis, genetics, specific protein markers, etc.) are collected. All the patients are followed up at M6, M12, M36 and M60. At each visit, the patients will have a clinical examination, neurological and psychiatric, in particular (disability, intercurrent events, etc.), and a battery (60-minute battery) of neuropsychological evaluations (executive functions, attention functions, memory functions, language, etc.), an MRI (white matter abnormalities, microbleeds, hippocampus and overall volumetry), an assessment of the changes in treatment, a drawing of blood samples to be used to follow up on the progression of the biomarkers. At M3, M24 and M48, telephone follow-up are done. Analysis strategy: The first part of the analysis will consist of studying the follow-up and incidence curves of the onset of dementia in the population as a whole using the Kaplan-Meier technique. The start of the dementia will be defined as the date of the diagnosis. The curves will be compared according to the etiological diagnosis of the dementia or the stroke by the log-rank test. An analysis using the Cox model will allow determination of the factors significantly related to the existence of dementia.

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Presenting Author
R.  Bordet  
Lille2 University 
Lille  
FRANCE

Trialist: clinicaltrial.gov : NCT01330160

Co- Authors 2-15:
 H.  Henon
Lille University Hospital   Lille   FRANCE

C.  Cordonnier
Lille2 University   Lille   FRANCE

C. Delmaire
Lille University Hospital   Lille   FRANCE

 C.  Lucas
Lille University Hospital   Lille   FRANCE

 D. Deplanque
 Lille2 University    Lille    FRANCE

X.  Leclerc
       

E.  Massardier
Rouen University Hospital  Rouen   FRANCE

 A.  Triquenot
Rouen University Hospital   Rouen   FRANCE

 P.  Gele
Lille University Hospital   Lille   FRANCE

A.M. Mendyk-Bordet
Lille University Hopsital    Lille   FRANCE

 D. Leys
Lille2 University   Lille   FRANCE

OAID 78

Subject area/topic: Ongoing Trial

ARUBA - A Randomized Trial of Unruptured Brain AVMs (NCT00389181)

RATIONALE: Current invasive treatment for brain arteriovenous malformations (AVMs) is varied and includes endovascular procedures, neurosurgery, and radiotherapy. However, no controlled studies on preventive interventions on the long-term outcome in patients with unruptured brain AVMs have yet been performed. DESIGN: ARUBA is an international, multicenter, randomized, controlled, open, prospective clinical trial. SAMPLE SIZE: 400 patients (1:1 random assignment). POPULATION STUDIED: Patients aged ≥18 years, diagnosed with an unruptured brain AVM considered by the local investigators to be suitable for attempted eradication. Outcome measures: The primary outcome is the composite event of death from any cause or stroke (hemorrhage or infarction confirmed by imaging). Clinical outcome status will be measured by the Rankin Scale, NIHSS, SF-36, and EuroQoL. INTERVENTIONS: Patients are randomly assigned to best possible invasive therapy (medical management plus endovascular, surgical, and/or radiation therapy ) versus medical management alone. Patients will be followed for 5-10 years from randomisation. PRIMARY AIM: To determine whether a strategy of medical management alone is superior to invasive therapy for preventing the composite outcome of death from any cause or stroke (symptomatic haemorrhage or infarction) in the treatment of unruptured BAVMs. SECONDARY AIM: To determine whether treatment of unruptured BAVMs by medical management alone decreases the risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization compared to invasive therapy. TRIAL STATUS: More than 195 patients have been enrolled worldwide. Interested multidisciplinary treatment teams are welcome to join. SPONSOR: NIH/NINDS (NCT00389181) CONTACT WORLD: jpm10@columbia.edu (www.arubastudy.org) CONTACT EUROPE: christian.stapf@lrb.aphp.fr

Graphic/Table:  
 

Presenting Author
C.  Stapf  
University Paris VII - Denis Diderot, Hôpital Lariboisière 
Paris  
FRANCE

Trialist: The International ARUBA Trialists

Co- Authors 2-15:
 J.P.  Mohr
Columbia University Medical Center   New York, NY   USA

A.J.  Moskowitz
InCHOIR, Mount Sinai Medical School   New York, NY   USA

M.K. Parides
InCHOIR, Mount Sinai Medical School   New York, NY   USA

 E.  Moquete
InCHOIR, Mount Sinai Medical School   New York, NY   USA

 C.S. Moy
 NIH/NINDS   Bethesda, MD    USA

E.  Vicaut
University Paris VII - Denis Diderot, Hôpital Lariboisière   Paris   FRANCE