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

NCT04624646 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Korea Health Industry Development Institute

    collaborator OTHER_GOV

  • Ewha Womans University Mokdong Hospital

    lead OTHER

Principal Investigators

  • Junbeom Park, M.D., PhD. · Ewha Womans University Mokdong Hospital

  • Tae-Jin Song, MD · Ewha Womans University Seoul Hospital

  • Dong-Hyeok Kim, MD · Ewha Womans University Seoul Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2025-11-01
Completion
2026-11-15
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624646 on ClinicalTrials.gov