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Trials ESC Barcelona, Spain 2010Input Ongoings
OAID1
Subject area/topic: Ongoing Trial
ICONS: Identifying Continence OptioNs after Stroke
Background
Urinary incontinence following acute stroke is common, affecting between 40%-60% of people admitted to hospital. It is distressing for those affected, is related to poor outcome and is currently poorly managed in many cases.
Our research programme aims to develop, implement and explore the potential effectiveness and cost-effectiveness of a systematic voiding programme for the management of urinary incontinence after stroke in hospital. The programme will include bladder training and pelvic floor muscle training for patients who are cognitively able and prompted voiding for patients with cognitive impairments.
The programme is based on the UK Medical Research Council (MRC) framework for the evaluation of complex interventions.
Methods
Phase I: MRC Development phase
• An evidence synthesis of qualitative and qualitative literature on combined approaches to managing urinary incontinence post-stroke.
• A case study of the introduction of the systematic voiding programme algorithm in one stroke service in the North West of England.
Phase II: MRC Feasibility and piloting phase (Exploratory trial)
Phase II aims to test the interventions for preliminary evidence of effect and feasibility. The trial will use cluster randomisation at the level of the stroke service and involve twelve stroke services randomised to receive:
• Systematic voiding programme (n=4)
• Systematic voiding programme plus supported implementation (n=4)
• Usual care (n=4)
Patient recruitment for this phase will take place between October 2010 and June 2011.
Trialist:
Presenting Author
L.
Thomas
University of Central Lancashire
Preston
UNITED KINGDOM
Co- Authors 2-15:
C.
Watkins
University of Central Lancashire
Preston
UNITED KINGDOM
B. French
University of Central Lancashire
Preston
UNITED KINGDOM
F. Cheater
Glasgow Caledonian University
Glasgow
UNITED KINGDOM
J. Booth
Glasgow Caledonian University
Glasgow
UNITED KINGDOM
B. Roe
Edge Hill University
Ormskirk
UNITED KINGDOM
C. Burton
Bangor University
Bangor
UNITED KINGDOM
M. Leathley
University of Central Lancashire
Preston
UNITED KINGDOM
C.
Sutton
University of Central Lancashire
Preston
UNITED KINGDOM
E. McColl
Newcastle University
Newcastle upon Tyne
UNITED KINGDOM
K Brittain
Newcastle University
Newcastle upon Tyne
UNITED KINGDOM
J. Gotaas
University of Central Lancashire
Preston
UNITED KINGDOM
B.
Carter
University of Central Lancashire
Preston
UNITED KINGDOM
H.
Rodgers
Newcastle University
Newcastle upon Tyne
UNITED KINGDOM
J. Barrett
Wirral University Teaching Hospital NHS Foundation Trust Liverpool UNITED KINGDOM
OAID2
Subject area/topic: Ongoing Trial
International Study of Primary Angiitis of the CEntral nervous system (I-SPACE): a proposal
BACKGROUND: Primary angiitis of the central nervous system (PACNS) is a rare, idiopathic vasculitis of the CNS. Current knowledge of PACNS is derived primarily from small, retrospective studies. Large multicentre prospective registries, (ex. International Study on Cerebral Vein and Dural Sinus Thrombosis) provide valuable insight into rare diseases. The objective of a PACNS registry is to better understand the clinical manifestations, imaging, histopathology, treatment and prognosis of PACNS.
METHODS: Adults diagnosed with PACNS (Calabrese and Mallek criteria) by site physicians within the last year will be approached to participate in the I-SPACE, an international multicentre, prospective registry. Baseline clinical data and investigation results will be collected using standardized, web-based case report forms as will therapeutic interventions, complications and relapses. Angiography, neuro-imaging and histopathology results will be reviewed centrally. New vessel-wall imaging techniques will also be explored.
RESULTS: This registry will include ≥20 international centres. Approximately 20 patients will be recruited per year for ≥5 years (≥ 100 patients). Patients will be followed for ≥1 year.
CONCLUSIONS: The I-SPACE data will help us reevaluate current knowledge of clinical, radiological and histopathological manifestations of PACNS and suggest optimal therapeutic approaches. To join the I-SPACE, please contact the authors: sylanthier@gmail.com.
Trialist: I-SPACE co-investigators
Presenting Author
J.
Kovitz-Lensch
Cerebrovascular Disease Centre, Division of Neurology, CHUM, and Faculty of Medicine, Université de Montréal
Montreal
CANADA
Co- Authors 2-15:
A.Y.
Poppe
Cerebrovascular Disease Centre, Division of Neurology, CHUM, and Faculty of Medicine, Université de Montréal
Montreal
CANADA
R. Swartz
Division of Neurology, Sunnybrook Health Sciences Centre, and Faculty of Medicine, University of Toronto
Toronto
CANADA
A. Demchuk
Department of Clinical Neurosciences, Foothills Medical Centre, and Faculty of Medicine, University of Calgary
Calgary
CANADA
J. Putaala
Department of Neurology, Helsinki University Central Hospital
Helsinki
FINLAND
J.M. Ferro
Serviço de Neurologia, Hospital de Santa Maria, Universidade de Lisboa
Lisbon
PORTUGAL
I. Crassard
Service de Neurologie, Hôpital Lariboisière
Paris
FRANCE
A. de Windt
Unité Neurovasculaire, Hôpital Saint Philibert, Institut Catholique de Lille
Lille
FRANCE
C.
Odier
Centre hospitalier Universitaire Vaudois
Lausanne
SWITZERLAND
P. Michel
Centre hospitalier Universitaire Vaudois
Lausanne
SWITZERLAND
S. Lanthier
Cerebrovascular Disease Centre, Division of Neurology, CHUM, and Faculty of Medicine, Université de Montréal
Montreal
CANADA
OAID3
Subject area/topic: Ongoing Trial
The Effects of Dual-Tasks on Walking and Cardiovascular Functions in Subjects with Stroke.
Background: The aim of this study was to examine the effects of dual-tasks (with cognitive functions and physical performance) on walking and cardiovascular functions in stroke patients.Methods: Four male and one female stroke subjects with avarage age of 55.40+/-10.11 were included to this study. The data included demographics, orthotic support, hemiplegic side, additional disease, smoking habbits. Walking and dynamic balance were assessed with Time Up and Go (TUG) test. In order to assess the effects of dual-tasks TUG was done free, with Weschler Memory Scale (WMS) to analyze cognitive function (TUG-cog) and with Cup Carrying Performance Test to analyze physical performance (TUG-cup). In all three TUG tests; breath and heart rate, systolic and dyastolic pressures were recorded as soon as the tests finished, at 3rd and 5th minutes recovery periods. Results: While three of five subjects had right sided hemiplegia, two of them were left sided. Patients had stroke approximately 12.9+/-16.53 months. When the results of TUG tests were compared, we found that there was significant difference between TUG-free and TUG-cup tests (p<0.05) whereas there was not any difference between TUG-free and TUG-cog (p>0.05). There was not any difference in cardiovascular recovery for all TUG tests (p>0.05). Conclusions: The results of this study showed that dual-tasks were important for daily life and causes additional efforts in walking and balance abilities. In addition to this, walking with physical performance was more difficult than the walking with cognitive performance. The cardiovascular recovery after free walking, walking with cognitive functions and walking with physical performance were almost same. However it sholud be remembered that the distance of TUG test (3m) may not be enough to cause a load in the cardiovascular system. We concluded that, walking with dual-tasks should be included in rehabilitation programs of stroke patients.
Trialist:
Presenting Author
O.
TELLI ATALAY
PAMUKKALE UNIVERSITY
DENIZLI
TURKEY
Co- Authors 2-15:
T.
CAN
PAMUKKALE UNIVERSITY
DENIZLI
TURKEY
E. BASKAN
PAMUKKALE UNIVERSITY
DENIZLI
TURKEY
N. CETISLI KORKMAZ
PAMUKKALE UNIVERSITY
DENIZLI
TURKEY
OAID4
Subject area/topic: Ongoing Trial
Stroke Telemedicine for Arizona Rural Residents Trial
Objective:
To establish a system for the prospective collection, recording, and analysis of telestroke trial patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other telestroke programs.
Design:
Prospective, interventional, treatment, open-label, active control, single group assignment, safety/efficacy trial. Sample size is 500 subjects.
Population Studied:
Consenting adult patients presenting to a participating rural emergency department within 12 hours of an acute stroke syndrome onset.
Intervention(s):
Two way site independent audio/video telemedicine system with DICOM and Smart Phone with teleradiology application
Outcome Measure(s):
Quality measures for telestroke consultations
Trial Status:
Oct 2008 to Dec 2009, 1 Primary Stroke Center (PSC) Hub, 7 vascular neurology investigators, 5 spoke hospitals, 55 emergency medicine investigators, 2 program managers, 3 information technology analysts, and 4 research coordinators participated. The network conducted 174 telestroke consultations. Symptom onset to ED arrival median 75 min, ED arrival to telestroke hotline activation median 28 min, telestroke hotline activation to return call median 1 min, consent signing to consult commencing median 14 min, consult start to treatment decision median 24 min, treatment decision to treatment administration median 18 min, symptom onset to thrombolysis administration median 165 min, ED arrival to thrombolysis administration median 92 min. Proportion arriving by EMS, 64%. Subjects received IV thrombolysis, 24%. Consultations were subjected to technical observations, 68%. Of those, 3% prevented decision making and 44% delayed decision making. The remainder were clinically inconsequential. ED admitting diagnosis ischemic stroke, IV thrombolysis administration 24%, ischemic stroke, no IV thrombolysis administration 39%, Transient Ischemic Attack 7%, Intracranial Hemorrhage 10%, Not Cerebrovascular Disorder 11%, Unknown 9%. Patient status after ED: Admitted to spoke 64%, transferred to PSC 24%, non-PSC 1%, home 11%.
Study Duration:
3 years of subject accrual and 3 months for follow-up
Trialist: STARR Trial Coordinators and Investigators
Presenting Author
B.
Demaerschalk
Mayo Clinic
Phoenix
USA
Co- Authors 2-15:
D
Channer
Mayo Clinic
Phoenix
USA
T. Kiernan
Mayo Clinic
Phoenix
USA
B. Bobrow
Maricopa Medical Center
Phoenix
USA
OAID5
Subject area/topic: Ongoing Trial
Baseline characteristics of the ROCKET AF study: comparison with recent atrial fibrillation studies
Background: Atrial fibrillation (AF), the most common cardiac arrhythmia, increases the risk of stroke. Warfarin is effective in reducing stroke risk but is burdensome and is difficult to control. Rivaroxaban is an oral, once-daily (od), direct Factor Xa inhibitor.
Methods: ROCKET AF is a randomized, double-blind, double-dummy, event-driven trial, comparing rivaroxaban with warfarin in patients with AF who have a history of stroke or at least two risk factors for future stroke. Patients are randomly assigned to receive rivaroxaban 20 mg od, or dose-adjusted warfarin titrated to a target international normalized ratio (INR) of 2.5 (range 2.0–3.0, inclusive) using point-of-care INR devices to receive true or sham INR values, depending on study drug allocation. The study is powered to show non-inferiority of rivaroxaban to warfarin for the composite of stroke and non-CNS systemic embolism (primary efficacy endpoint); and if demonstrated, superiority will be tested. The primary safety endpoint is the composite of major and clinically relevant non-major bleeding events. 14,269 patients were randomized from December 2006 until June 2009, and this event-driven trial will run for about 40 months.
Results: Baseline patient data from ROCKET AF and recent AF trials are shown in the Table.
Conclusion: ROCKET AF will determine the efficacy and safety of rivaroxaban compared with warfarin for the prevention of thromboembolism in a higher-risk set of patients with AF than enrolled in previous trials of novel agents.
Graphic:
Table:
http://www.eurostroke.org/graphics_barcelona/oaid_5.html
Trialist: N/A
Presenting Author
M.R.
Patel
Duke Clinical Research Institute, Duke University
Durham NC
USA
Co- Authors 2-15:
R.C.
Becker
G. Breithardt
W. Hacke
J. Halperin
G. Hankey
K. Mahaffey
C. Nessel
J.
Paolini
J. Piccini
D. Singer
R. Califf
K.
Fox
OAID6
Subject area/topic: Ongoing Trial
A pivotal study evaluating the Ischemic Stroke System (ISS*) for treatment of Acute Ischemic Stroke up to 24 hours from stroke onset.
Background: A recent clinical pilot study (ImpACT-1), evaluated a novel device (the ISS) for the treatment of AIS in the anterior circulation up to 24 hours after stroke onset. The ISS contains an implantable neurostimulator (INS) designed to deliver stimulation to the sphenopalatine ganglion (SPG) situated outside the cranium. The open labeled pilot study compared 98 patients treated using the ISS to historical matched patients from the NINDS control arm. Results suggest that treatment is safe and efficacious (mean 90 day mRS score of patients is significantly lower (CMH test p = 0.001); 48% compared to 29% of patients demonstrated a favorable mRS outcome (mRS 0-2) (p=0.003).
Design: ImpACT-24 is a multinational pivotal study. It is a double blind sham control study. Patients are randomized to either ISS Stimulation or Sham Control in a 2:1 ration. 600 patients with AIS in the anterior circulation, baseline NIHSS 7-18 and ability to initiate treatment 8-24hrs from stroke onset will be enrolled. The ISS is implanted, to all patients, adjacent to the SPG through the greater palatine canal using a minimal invasive approach. ISS/sham stimulation is applied 4 hours daily for 5 consecutive days. Efficacy is assessed by mRS and NIHSS at 90 days. Safety is assessed by incidence of adverse events.
Results: To date, 128 patients have been enrolled. Mean age 68.9 yrs, mean treatment time from stroke onset 18 hrs, Median baseline NIHSS 12.1 (range 7-18). Mortality and SAE rates (14% and 25.7% respectively) are within the expected range.
Conclusion: ImpACT-24 is a multinational, randomized, double blind study with sham control (2:1) based on a clinical pilot study. It is designed to assess the effectiveness and safety of a novel device (ISS) for the treatment of AIS in a much needed broader therapeutic window than currently available.
* CAUTION — Investigational device. Limited by Federal (or United States) law to investigational use.
Trialist: NCT 00826059
Presenting Author
C.A.
Molina
Hospital Universitari Vall d’Hebron
Barcelona
SPAIN
Co- Authors 2-15: