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| Study 1 of 4 for search of: | David J. Gladstone MD, PhD |
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| Sponsor: | Sunnybrook Health Sciences Centre |
|---|---|
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00846924 |
Purpose
Atrial fibrillation is the most common cardiac cause of ischemic stroke. Detecting atrial fibrillation after a stroke or TIA is critical because highly effective secondary stroke prevention therapy is available for individuals who are recognized to have atrial fibrillation. However, atrial fibrillation is likely under-diagnosed after stroke and TIA because atrial fibrillation is often difficult to detect as it is frequently paroxysmal and asymptomatic, and patients do not routinely undergo prolonged screening. The purpose of this study is to determine the diagnostic yield of a novel 30-day cardiac event monitor compared to a repeat 24-hour Holter monitor for detecting occult paroxysmal atrial fibrillation in patients with a recent ischemic stroke or TIA of undetermined etiology after completion of a standard clinical stroke work-up (including an initial negative Holter monitor.)
| Condition | Intervention |
|---|---|
|
Stroke Transient Ischemic Attack Atrial Fibrillation Atrial Flutter |
Device: a 30-day ambulatory cardiac event monitor Device: 24-hour Holter |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | 30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event: A Randomized Controlled Trial |
| Estimated Enrollment: | 564 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| repeat 24-hour Holter monitor: Active Comparator |
Device: 24-hour Holter
Repeat standard 24-hour Holter Monitor
|
| 30-day ambulatory cardiac event monitor: Experimental |
Device: a 30-day ambulatory cardiac event monitor
Patients will be fitted with dry electrode belt (including cardiac event monitor)and instructed to wear the device for as many hours(waking and sleeping) each day as possible, for a total of 30 days.
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion:
Diagnosis of the index event* made by a stroke specialist of an acute ischemic stroke or TIA (WHO definition) occurring within the previous 90 days. The event must be either:
Patient meets the following:
The following diagnostic tests have already been completed as part of clinical routine post-stroke/TIA:
The patient has a valid provincial health insurance number.
Exclusion:
Contacts and Locations| Canada, Alberta | |
| Foothills Medical Centre | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Karyn Fischer karyn.fischer@albertahealthservces.ca | |
| Principal Investigator: Shelagh Coutts, MD FRCPC | |
| Canada, British Columbia | |
| Vancouver Island Health Research Centre (VIHA) | Recruiting |
| Victoria, British Columbia, Canada | |
| Contact: Karen Coles karen.coles@viha.ca | |
| Principal Investigator: Andrew Penn, MD FRCPC | |
| Vancouver Hospital and Health Sciences Centre | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Karina Murray karina@bcstrokecentre.ca | |
| Principal Investigator: Samuel Yip, MD FRCPC | |
| Principal Investigator: Philip Teal, MD FRCPC | |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Gil Valencia gil.valencia@sunnybrook.ca | |
| Principal Investigator: David Gladstone, MD FRCPC PhD | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Contact: Connie Frank Connie.frank@lhsc.on.ca | |
| Principal Investigator: Vladimir Hachinski, MD FRCPC | |
| Robarts Research Institute | Recruiting |
| London, Ontario, Canada | |
| Contact: Tisha Mabb tisha@robarts.ca | |
| Principal Investigator: David Spence, MD FRCPC | |
| UHN / Toronto Western Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Cherissa Astorga Cherissa.Astorga@uhn.on.ca | |
| Principal Investigator: Leanne Casaubon, MD FRCPC | |
| Hamilton Health Sciences Centre | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Janice Sancan sancan@hhsc.ca | |
| Principal Investigator: Demetrios Sahlas, MD FRCPC | |
| Ottawa Hospital Research Institute -The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Melodie Mortensen MMortensen@ottawahospital.on.ca | |
| Principal Investigator: Michael Sharma, MD FRCPC | |
| Thunder Bay Regional HSC | Recruiting |
| Thunder Bay, Ontario, Canada | |
| Contact: Sandra Stoger Stogers@iisrc.net | |
| Principal Investigator: David Howse, MD FRCPC | |
| Canada, Quebec | |
| CHA-Hôpital de l'Enfant-Jesus | Recruiting |
| Quebec City, Quebec, Canada | |
| Contact: Claudette Lessard claudette.lessard.cha@ssss.gouv.qc.ca | |
| Principal Investigator: Steve Verreault, MD FRCPC | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Lisa Wadup lisa.wadup@muhc.mcgill.ca | |
| Principal Investigator: Robert Cote, MD FRCPC | |
| Principal Investigator: | David J Gladstone, MD, PhD, FRCPC | Sunnybrook Women's Health Sciences Centre |
More Information
| Responsible Party: | Sunnybrook Health Sciences Centre ( Dr. David Gladstone, MD, PhD, FRCPC ) |
| Study ID Numbers: | Embrace001 |
| Study First Received: | February 18, 2009 |
| Last Updated: | October 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00846924 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Stroke Transient Ischemic Attack Atrial fibrillation Atrial flutter |
|
Ischemic Attack, Transient Heart Diseases Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Atrial Flutter Pathologic Processes Brain Ischemia Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |