30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event
- Conditions
- StrokeAtrial FibrillationAtrial FlutterTransient Ischemic Attack
- Interventions
- Device: 24-hour HolterDevice: a 30-day ambulatory cardiac event monitor
- Registration Number
- NCT00846924
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 564
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description repeat 24-hour Holter monitor 24-hour Holter - 30-day ambulatory cardiac event monitor a 30-day ambulatory cardiac event monitor -
- Primary Outcome Measures
Name Time Method Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up 90 days
- Secondary Outcome Measures
Name Time Method Atrial fibrillation <30 seconds 90 days Atrial flutter <30 seconds 90 days Non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of atrial fibrillation) 90 days Proportion of patients in each group that are prescribed oral anticoagulation, as assessed at the 90-day follow-up 90 days Patient adherence with 30-day monitoring: average proportion of days wearing the monitor per patient, and the percentage of patients wearing the monitor for >75% of the target period 90 days 1 and 2-year recurrence of ischemic stroke/TIA, death, hemorrhagic stroke, major adverse bleeding event, detection of atrial fibrillation outside of the study protocol 2 years composite endpoint of: (1) AF >30 seconds, (2) non-sustained (>3 beats, <30 seconds) irregular atrial tachyarrhythmia (including brief runs of AF), or (3) atrial flutter. 90 days
Trial Locations
- Locations (17)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Hamilton Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
CHA-Hôpital de l'Enfant-Jesus
🇨🇦Quebec City, Quebec, Canada
Grey Nuns Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver Hospital and Health Sciences Centre
🇨🇦Vancouver, British Columbia, Canada
Robarts Research Institute
🇨🇦London, Ontario, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Walter C. Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
Vancouver Island Health Research Centre (VIHA)
🇨🇦Victoria, British Columbia, Canada
UHN / Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Research Institute -The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Thunder Bay Regional HSC
🇨🇦Thunder Bay, Ontario, Canada
York Central Hospital
🇨🇦Toronto, Ontario, Canada