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

NCT ID: NCT04624646

Last Updated: 2023-01-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2025-09-18

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.

Detailed Description

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Conditions

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Atrial Fibrillation Ischemic Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

24-hour Holter monitoring

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Discontinuous monitoring

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Continuous single-lead ECG Patch

Intervention Type DEVICE

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

Intervention Type DEVICE

Continuous single-lead ECG Patch

Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke

Intervention Type DEVICE

24-hour Holter monitoring

Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Ewha Womans University Seoul Hospital

Gangseo, Seoul, South Korea

Site Status RECRUITING

Hanyang University Seoul Hospital

Seongdong, Seoul, South Korea

Site Status RECRUITING

Ewha Womans University Mokdong Hospital

Yangcheon, Seoul, South Korea

Site Status RECRUITING

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Gachon University Gil Hospital

Incheon, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital

Seoul, , South Korea

Site Status RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Junbeom Park, M.D.,PhD

Role: CONTACT

+821035399822

Sodam Jung, M.D.

Role: CONTACT

+821073209202

Facility Contacts

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Professor

Role: primary

Dong-Hyeok Kim, MD

Role: primary

Jinkyu Park, M.D.,PhD.

Role: primary

Suhe Kwon

Role: primary

+82 2-2650-5865

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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