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Active, Not Recruiting

NCT Number: NCT04624646

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Attack, Transient Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Transient Ischemic Attack Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Yongin Severance Hospital, Yongin, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discontinuous monitoring

Device

Discontinuous ECG monitoring by finger contact every day

Continuous single-lead ECG Patch

Device

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

24-hour Holter monitoring

Device

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

Primary outcomes

  1. Atrial fibrillation detection rate

    Time frame: Until 1 year after stroke

    Compare detection rates of each arms

Secondary outcomes

  1. Change from antiplatelet therapy to anticoagulants following AF detection

    Time frame: Until 1 year after stroke

    Change from antiplatelet therapy to anticoagulants following AF detection

  2. Major adverse cardiac and cerebrovascular event

    Time frame: Until 1 year after stroke

    composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  3. Re-admission

    Time frame: Until 1 year after stroke

    Re-admission

  4. All-cause death

    Time frame: Until 1 year after stroke

    All-cause death

Other outcomes

  1. Major bleeding

    Time frame: Until 1 year after stroke

    Fatal or overt bleeding with a drop in hemoglobin level of at least 2 g/dL or requiring transfusion of at least 2 units packed blood cells, or critical anatomical site hemorrhage (e.g., intracranial, retroperitoneal)

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

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

Acronym: CANDLE-AF

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 12, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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