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Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke
Sponsor: Ewha Womans University Mokdong Hospital
Summary
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2020-11-17
Completion Date
2026-07-08
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
Ambulatory Holter monitoring
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
Discontinuous monitoring
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
Continuous single-lead ECG Patch
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
Locations (7)
Ewha Womans University Seoul Hospital
Gangseo, Seoul, South Korea
Hanyang University Seoul Hospital
Seongdong, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Ewha Womans University Mokdong Hospital
Yangcheon, Seoul, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea