30-Day Cardiac Event Monitor Belt for Recording Atrial Fibrillation After a Cerebral Ischemic Event

Not Applicable

• Conditions: Stroke; Atrial Fibrillation; Atrial Flutter; Transient Ischemic Attack

• 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

Study Timeline

• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Study Start: 2009-05
• Primary Completion: 2014-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-05
• Study Completion: 2018-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 564

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Grey Nuns Hospital; 🇨🇦 Edmonton, Alberta, Canada

Walter C. Mackenzie Health Sciences Centre; 🇨🇦 Edmonton, Alberta, Canada

Vancouver Hospital and Health Sciences Centre; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver Island Health Research Centre (VIHA); 🇨🇦 Victoria, British Columbia, Canada

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Robarts Research Institute; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Research Institute -The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

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