NCT04624646

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Ischemic Stroke
• Transient Ischemic Attack

Interventions

Type	Name	Description
DEVICE	Discontinuous monitoring	Discontinuous ECG monitoring by finger contact every day
DEVICE	Continuous single-lead ECG Patch	Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke
DEVICE	24-hour Holter monitoring	Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke

Timeline

• Start date: 2020-11-17
• Primary completion: 2024-09-18
• Completion: 2025-09-18
• First posted: 2020-11-12
• Last updated: 2023-01-26

Locations

9 sites across 1 country: South Korea

Regulatory

• FDA-regulated device study