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

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Atrial Fibrillation; Transient Ischemic Attack
• Interventions: Device: Discontinuous monitoring; Device: Continuous single-lead ECG Patch; Device: 24-hour Holter monitoring

• Registration Number: NCT04624646
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2020-11-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2024-09-18
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Newly diagnosed brain infarction
• No history and diagnosis of atrial fibrillation at the time of admission
• Rejected implantable loop recorder
• Informed consent

Read More

Exclusion Criteria

• Cannot use KardiaMobile system alone or with the help of others

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinuous Monitoring Group	Discontinuous monitoring	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.
Single-lead Continuous Patch Group	Continuous single-lead ECG Patch	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.
Conventional Holter Monitoring Group	24-hour Holter monitoring	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.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation detection rate	Until 1 year after stroke	Compare detection rates of each arms

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular event	Until 1 year after stroke	composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Recurrent stroke	Until 1 year after stroke	Recurrent stroke

Trial Locations

Locations (9)

Yonsei University Health System, Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of

Ewha Womans University Seoul Hospital; 🇰🇷 Gangseo, Seoul, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Yangcheon, Seoul, Korea, Republic of

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seongdong, Seoul, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of