Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke

Study Overview
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Brief Summary
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It is known that atrial fibrillation after stroke significantly increases the risk of stroke or systemic embolism. Accordingly, efforts have been made to detect hidden atrial fibrillation and apply treatment using anticoagulants instead of antiplatelet agents. The conventional method used to screen for atrial fibrillation in stroke patients who did not have atrial fibrillation at first admission is 24-hour Holter monitoring. This study will compare the detection rate of atrial fibrillation with discontinuous ECG monitoring three times a day and 72 hours of single-lead ECG patch monitoring compared with the conventional Holter test.

Official Title
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Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke - The Comparison Between Short-term Continuous Patch and Long-term Discontinuous Monitoring

Conditions
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Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Device: Discontinuous monitoring
* Device: Continuous single-lead ECG Patch
* Device: 24-hour Holter monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed brain infarction No history and diagnosis of atrial fibrillation at the time of admission Rejected implantable loop recorder Informed consent Exclusion Criteria: Cannot use KardiaMobile system alone or with the help of others

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Holter Monitoring Group<br>Holter monitoring is performed for 24 hours each at 1, 3, and 12 months after the diagnosis of stroke, and if atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. | Device: 24-hour Holter monitoring<br>* Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke<br>|
| Experimental: Discontinuous Monitoring Group<br>Discontinuous ECG monitoring by finger contact is performed 3 times every day for 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. | Device: Discontinuous monitoring<br>* Discontinuous ECG monitoring by finger contact every day<br>|
| Experimental: Single-lead Continuous Patch Group<br>Continuous 72 hours of ECG monitoring by a single-lead patch is performed at a week and 1, 3, 6, 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. | Device: Continuous single-lead ECG Patch<br>* Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation detection rate | Compare detection rates of each arms | Until 1 year after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke | Recurrent stroke | Until 1 year after stroke | 
| Major adverse cardiac and cerebrovascular event | composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death | Until 1 year after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack