Post-stroke heart rhythm monitoring with a wearable chest patch in Southern Norway
The Southern-Norway Post-Stroke Atrial Fibrillation Study
This test tries a small wireless chest patch worn up to 14 days to see if it finds atrial fibrillation better than the usual short hospital monitoring in people who recently had an ischemic stroke or TIA.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sorlandet Hospital HF Government |
| Locations | 1 site (Kristiansand) |
| Trial ID | NCT07407790 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, parallel-group trial at a single Norwegian stroke center enrolling about 450 adults admitted with ischemic stroke or TIA within the past two weeks. Participants are randomized 1:1 (stratified by age) to either continuous monitoring with the ECG247 Smart Heart Sensor patch worn up to 14 days and linked to a smartphone, or to standard in-hospital care which typically includes 24–48 hour Holter or telemetry monitoring. The primary focus is detection of intermittent atrial fibrillation missed by short-duration monitoring, with secondary consideration of clinical utility and cost-effectiveness. Data collection occurs during the monitoring period and through follow-up per protocol to capture detected AF and related management changes.
Who should consider this trial
Good fit: Adults hospitalized with ischemic stroke or TIA within the last two weeks (including amaurosis fugax), with a smartphone and Norwegian permanent address, estimated life expectancy >6 months, who can provide informed consent and do not have known AF or current anticoagulation.
Not a fit: Patients with previously known atrial fibrillation or already on anticoagulant treatment, those without a compatible smartphone or Norwegian residence, or those unable to wear the patch are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the patch approach could find more cases of intermittent AF earlier so more patients can start anticoagulation and lower their risk of another stroke.
How similar studies have performed: Previous research using longer-duration ambulatory ECG patches and extended monitoring has generally shown higher AF detection rates than short-duration Holter monitoring, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients hospitalized with an ischemic stroke or transient ischemic attack (TIA), including amaurosis fugax, occurring within the last 2 weeks. * Initial evaluation of CT and/or CT angiography and/or MRI supports a diagnosis of TIA or ischemic stroke. * Available smartphone and access to the ECG247-app to be able to participate in the study. * Estimated life span of \>6 month * Permanent address in Norway * Informed Consent, Capable of giving signed informed consent or consent through proxy as described in Appendix which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions * Known AF or atrial flutter prior to inclusion * Concomitant use of anticoagulation therapy or established contraindication to its use. To date this includes apixaban, rivaroxaban, edoxaban, dabigatran, warfarin and indirect thrombin inhibitors (except for short term thrombosis prevention). * Implanted pacemaker, ICD or loop-recorder * \>70% stenosis of carotid artery on ipsilateral side to the stroke on CT angiography or ultrasound * Pregnancy
Where this trial is running
Kristiansand
- Sørlandet Sykehus HF — Kristiansand, Norway (Recruiting)
Study contacts
- Study coordinator: Halvor Oeygarden, PhD
- Email: halvor.oygarden@sshf.no
- Phone: +4747621336
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.