Screening for Atrial Fibrillation After Stroke
A Multicenter, National, Investigator-initiated, Randomized, Parallel-group, Registerbased Superiority Study to Compare Extended ECG Monitoring Versus Standard ECG Monitoring of 1-2 Days in Elderly Patients With Ischemic Stroke or TIA.
This study tests if more thorough heart rhythm checks can help older stroke patients avoid future strokes and other serious problems compared to regular checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3300 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05134454 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of extended ECG screening for atrial fibrillation in patients aged 70 and older who have recently experienced an ischemic stroke or transient ischemic attack (TIA). The study aims to determine if this enhanced screening can reduce the risk of recurrent stroke, death, and intracranial bleeding compared to standard ECG screening. It will also assess secondary outcomes such as major bleeding events, myocardial infarction, and the prevalence of atrial fibrillation, as well as the cost-effectiveness of the intervention. The study is designed as a nationwide, randomized, register-based trial.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 years and older who have been diagnosed with ischemic stroke or TIA within the last 14 days.
Not a fit: Patients with a prior diagnosis of atrial fibrillation or those who cannot receive oral anticoagulant treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the risk of recurrent strokes and improve treatment outcomes for elderly patients post-stroke.
How similar studies have performed: While there is limited evidence from previous studies on the benefits of ECG investigations post-stroke, this approach is considered a priority in clinical guidelines, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 70 years * A diagnosis of ischemic stroke or TIA within 14 days from inclusion. Exclusion Criteria: * Previously diagnosed atrial fibrillation * Contraindication to oral anticoagulant treatment according to Summary of Product Characteristics. * Indication for anticoagulant treatment other than atrial fibrillation, e.g. venous thromboembolism or mechanical heart valve prosthesis * Dual antiplatelet therapy not interchangeable to oral anticoagulation * Patients with pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor. * Patients who, according to the investigator, will not be able to comply with the study protocol.
Where this trial is running
Stockholm
- Karolinska Institutet Danderyds University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Johan Engdahl, MD, PhD
- Email: johan.engdahl@sll.se
- Phone: +46737593374
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.