Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke
NCT ID: NCT04624646
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2020-11-17
2025-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Conventional Holter Monitoring Group
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.
24-hour Holter monitoring
Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke
Discontinuous Monitoring Group
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.
Discontinuous monitoring
Discontinuous ECG monitoring by finger contact every day
Single-lead Continuous Patch Group
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.
Continuous single-lead ECG Patch
Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke
Interventions
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Discontinuous monitoring
Discontinuous ECG monitoring by finger contact every day
Continuous single-lead ECG Patch
Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke
24-hour Holter monitoring
Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke
Eligibility Criteria
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Inclusion Criteria
* No history and diagnosis of atrial fibrillation at the time of admission
* Rejected implantable loop recorder
* Informed consent
Exclusion Criteria
20 Years
80 Years
ALL
No
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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Principal Investigators
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Junbeom Park, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Mokdong Hospital
Tae-Jin Song, MD
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Seoul Hospital
Dong-Hyeok Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Seoul Hospital
Locations
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Yonsei University Health System, Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Ewha Womans University Seoul Hospital
Gangseo, Seoul, South Korea
Hanyang University Seoul Hospital
Seongdong, Seoul, South Korea
Ewha Womans University Mokdong Hospital
Yangcheon, Seoul, South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Professor
Role: primary
Dong-Hyeok Kim, MD
Role: primary
Jinkyu Park, M.D.,PhD.
Role: primary
Young-Soo Lee, MD
Role: primary
Ye-min Park, MD
Role: primary
Jung Myung Lee, MD
Role: primary
Young Dae Kim
Role: primary
Seung-Young Roh, MD
Role: primary
Other Identifiers
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CANDLE-AF Trial
Identifier Type: -
Identifier Source: org_study_id
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