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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke; Atrial Fibrillation; Transient Ischemic Attack
• Intervention / Treatment: Device: 24-hour Holter monitoring; Device: Discontinuous monitoring; Device: Continuous single-lead ECG Patch

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea
    • Daegu Catholic University Medical Center
  • Incheon, South Korea, 21565
    • Gachon University Gil Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 06273
    • Yonsei University Health System, Severance Hospital
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 17046
      • Yonsei University Health System, Yongin Severance Hospital
  • Seoul
    • Gangseo, Seoul, South Korea, 07985
      • Ewha Womans University Seoul Hospital
    • Seongdong, Seoul, South Korea, 04763
      • Hanyang University Seoul Hospital
    • Yangcheon, Seoul, South Korea, 07985
      • Ewha Womans University Mokdong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 24-hour Holter monitoring; Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke
Experimental: 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.	Device: Discontinuous monitoring; Discontinuous ECG monitoring by finger contact every day
Experimental: 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.	Device: Continuous single-lead ECG Patch; Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebrovascular event	composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	Until 1 year after stroke
Change from antiplatelet therapy to anticoagulants following AF detection	Change from antiplatelet therapy to anticoagulants following AF detection	Until 1 year after stroke
Re-admission	Re-admission	Until 1 year after stroke
All-cause death	All-cause death	Until 1 year after stroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	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)	Until 1 year after stroke

Collaborators and Investigators

• Sponsor: Ewha Womans University Mokdong Hospital
• Collaborators: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Junbeom Park, M.D., PhD., Ewha Womans University Mokdong Hospital; Principal Investigator: Tae-Jin Song, MD, Ewha Womans University Seoul Hospital; Principal Investigator: Dong-Hyeok Kim, MD, Ewha Womans University Seoul Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): November 1, 2025
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ischemic Stroke; Transient Ischemic Attack
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Brain Ischemia; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: CANDLE-AF Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes