Post-stroke heart rhythm monitoring with a wearable chest patch in Southern Norway

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sørlandet Sykehus HF
  Kristiansand, Norway Recruiting

Study contacts

• Study coordinator: Halvor Oeygarden, PhD
• Email: halvor.oygarden@sshf.no
• Phone: +4747621336

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.