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30-day ambulatory cardiac event monitor for Atrial Fibrillation (EMBRACE Trial)

N/A
Waitlist Available
Led By David J Gladstone, MD, PhD, FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
an embolic arterial ischemic stroke confirmed by neuroimaging; or a transient ischemic attack, defined as involving a focal unilateral motor deficit, speech/language deficit, or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events).
At least one 12-lead ECG has already been obtained as part of the routine clinical post-stroke/TIA work-up, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter, and;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

EMBRACE Trial 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.)

Eligible Conditions
  • Atrial Fibrillation
  • Atrial Flutter
  • Stroke
  • Mini Stroke

EMBRACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

EMBRACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of one or more episodes of atrial fibrillation or atrial flutter ≥30 seconds, as assessed at the 90 day follow-up
Secondary outcome measures
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
Atrial fibrillation <30 seconds
Atrial flutter <30 seconds
+4 more

EMBRACE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 30-day ambulatory cardiac event monitorExperimental Treatment1 Intervention
Group II: repeat 24-hour Holter monitorActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
651 Previous Clinical Trials
1,542,125 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
5,371 Patients Enrolled for Atrial Fibrillation
David J Gladstone, MD, PhD, FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~36 spots leftby Mar 2025