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

NCT04624646 | Unknown DMC FDA Device

• 1 other identifier: CANDLE-AF Trial
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 9

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.

Conditions

Atrial Fibrillation; Ischemic Stroke; Transient Ischemic Attack

Keywords

Atrial fibrillation; Ischemic Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation detection rate

  Compare detection rates of each arms

  Until 1 year after stroke

Secondary Outcomes (2)

• Recurrent stroke

  Until 1 year after stroke

• Major adverse cardiac and cerebrovascular event

  Until 1 year after stroke

Study Arms (3)

Conventional Holter Monitoring Group

ACTIVE COMPARATOR

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

Discontinuous Monitoring Group

EXPERIMENTAL

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

Single-lead Continuous Patch Group

EXPERIMENTAL

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

Interventions

Discontinuous monitoring DEVICE

Discontinuous ECG monitoring by finger contact every day

Discontinuous Monitoring Group

Continuous single-lead ECG Patch DEVICE

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

Single-lead Continuous Patch Group

24-hour Holter monitoring DEVICE

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

Conventional Holter Monitoring Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed brain infarction
• No history and diagnosis of atrial fibrillation at the time of admission
• Rejected implantable loop recorder
• Informed consent

You may not qualify if:

• Cannot use KardiaMobile system alone or with the help of others

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (9)

Yonsei University Health System, Yongin Severance Hospital

Yongin, Gyeonggi-do, 17046, South Korea

NOT YET RECRUITING

Ewha Womans University Seoul Hospital

Gangseo, Seoul, 07985, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seongdong, Seoul, 04763, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Yangcheon, Seoul, 07985, South Korea

RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Gachon University Gil Hospital

Incheon, 21565, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, 02447, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, 06273, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke; Ischemic Attack, Transient

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junbeom Park, M.D.,PhD

CONTACT

+821035399822; parkjb@ewha.ac.kr

Sodam Jung, M.D.

CONTACT

+821073209202; cvdosam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: November 17, 2020
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2025
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

KR (9)