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

Atrial Fibrillation Clinical Trial

— CANDLE-AF  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624646
• Other study ID #: CANDLE-AF Trial
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: September 18, 2025

Study information

• Verified date: January 2023
• Source: Ewha Womans University Mokdong Hospital
• Contact: Junbeom Park, M.D.,PhD
• Phone: +821035399822
• Email: parkjb[@]ewha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 18, 2025
• Est. primary completion date: September 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Device:
• Discontinuous monitoring
Discontinuous ECG monitoring by finger contact every day
• Continuous single-lead ECG Patch
Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke
• 24-hour Holter monitoring
Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Ewha Womans University Seoul Hospital	Gangseo	Seoul
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Hanyang University Seoul Hospital	Seongdong	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Yangcheon	Seoul
Korea, Republic of	Yonsei University Health System, Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation detection rate	Compare detection rates of each arms	Until 1 year after stroke
Secondary	Recurrent stroke	Recurrent stroke	Until 1 year after stroke
Secondary	Major adverse cardiac and cerebrovascular event	composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	Until 1 year after stroke