B2AD-Risk: How atrial fibrillation burden changes after ischemic stroke
Evolution of Burden of AF Biomarkers, Left Atrial Characteristics, Demographics,and Risk Factors in AF Detected After Stroke
This project will try continuous implantable heart-rhythm monitoring to see how atrial fibrillation changes over time in people newly diagnosed with AF after an ischemic stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06589700 on ClinicalTrials.gov |
What this trial studies
Researchers will implant loop recorders in adults who had a recent cortical or subcortical ischemic stroke and were newly diagnosed with paroxysmal AF to continuously record heart rhythms. They will track changes in AF episode frequency and duration, measure blood biomarkers of cardiac health, and image the left atrium to follow size and function over time. Patients will be grouped by how their AF was first detected (known before stroke, found on admission ECG, or found on 14-day Holter) and followed with regular clinic visits. Permanent or persistent AF and inability to consent are exclusion criteria; all procedures occur at a single center.
Who should consider this trial
Good fit: Adults with a recent cortical or subcortical ischemic stroke who were newly diagnosed with paroxysmal AF (known before stroke, detected on admission ECG, or detected on 14-day Holter) and who agree to receive an implantable loop recorder.
Not a fit: Patients with permanent or persistent AF, those unwilling to undergo an implantable monitor, or those with relevant contraindications (for example allergy to iodinated contrast agents) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors better tailor anticoagulation and other stroke-prevention strategies by revealing which patients develop more frequent or severe AF after stroke.
How similar studies have performed: Prior intensive cardiac-monitoring studies after ischemic stroke have successfully detected new AF and informed anticoagulation decisions, so this work builds on established monitoring methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke * Any of the following types of AF: * Paroxysmal AF known before stroke onset (KAF). * Paroxysmal AF found on an admission or Emergency Department ECG (ECG-AFDAS) * Paroxysmal AF found on 14-day Holter monitoring (PCM-AFDAS) Exclusion Criteria: * Patients not willing to consent * Permanent or persistent AF * Allergy to iodinated contrast agents
Where this trial is running
London, Ontario
- Heart and Brain Lab, Western University — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Luciano A Sposato, MD — Western University
- Study coordinator: Diana Ayan, Pharm MSc
- Email: diana.ayan@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.