Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke (CANDLE-AF)

Ewha Womans University

Status: Enrolling

Conditions: Ischemic Stroke; Atrial Fibrillation; Transient Ischemic Attack

Treatments: Device: Discontinuous monitoring; Device: Continuous single-lead ECG Patch; Device: 24-hour Holter monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04624646

CANDLE-AF Trial

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Conventional Holter Monitoring Group

Active Comparator group

Description:

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.

Treatment:

Device: 24-hour Holter monitoring

Discontinuous Monitoring Group

Experimental group

Description:

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.

Treatment:

Device: Discontinuous monitoring

Single-lead Continuous Patch Group

Experimental group

Description:

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.

Treatment:

Device: Continuous single-lead ECG Patch