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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04624646

Acronym

CANDLE-AF

Enrollment

600

Registered

2020-11-12

Start date

2020-11-17

Completion date

2025-09-18

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack

Keywords

Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack

Brief 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.

Interventions

DEVICEDiscontinuous monitoring

Discontinuous ECG monitoring by finger contact every day

DEVICEContinuous single-lead ECG Patch

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

DEVICE24-hour Holter monitoring

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Atrial fibrillation detection rate	Until 1 year after stroke	Compare detection rates of each arms

Secondary

Measure	Time frame	Description
Recurrent stroke	Until 1 year after stroke	Recurrent stroke
Major adverse cardiac and cerebrovascular event	Until 1 year after stroke	composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

Countries

South Korea

Contacts

Primary ContactJunbeom Park, M.D.,PhD

parkjb@ewha.ac.kr+821035399822

Backup ContactSodam Jung, M.D.

cvdosam@gmail.com+821073209202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026