Published Ongoing Trials ESC Lisbon 2012

OAID2

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

     
        

OAID3

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

OAID4

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

OAID6

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:
     
       

OAID7

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

OAID8

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

OAID9

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:
     
       

OAID11

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