NCT05134454 Atrial Fibrillation Screening Post Ischemic Cerebrovascular Events
| NCT ID | NCT05134454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,300 participants |
| Start Date | 2022-01-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,300 participants in total. It began in 2022-01-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke. It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke. There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines. Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility. The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers. The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.
Eligibility 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.
Contact & Investigator
Johan Engdahl, MD, PhD
STUDY CHAIR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05134454 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05134454 currently recruiting?
Yes, NCT05134454 is actively recruiting participants. Contact the research team at johan.engdahl@sll.se for enrollment information.
Where is the NCT05134454 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05134454 clinical trial?
NCT05134454 is sponsored by Karolinska Institutet. The principal investigator is Johan Engdahl, MD, PhD at Karolinska Institutet. The trial plans to enroll 3,300 participants.
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