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

Primary Purpose

Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Discontinuous monitoring

Continuous single-lead ECG Patch

24-hour Holter monitoring

About this trial

This is an interventional screening trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Yonsei University Health System, Yongin Severance Hospital
Ewha Womans University Seoul HospitalRecruiting
Hanyang University Seoul HospitalRecruiting
Ewha Womans University Mokdong HospitalRecruiting
Daegu Catholic University Medical CenterRecruiting
Gachon University Gil HospitalRecruiting
Kyung Hee University HospitalRecruiting
Yonsei University Health System, Severance HospitalRecruiting
Korea University Guro HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Holter Monitoring Group

Discontinuous Monitoring Group

Single-lead Continuous Patch Group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Atrial fibrillation detection rate

Compare detection rates of each arms

Secondary Outcome Measures

Recurrent stroke

Major adverse cardiac and cerebrovascular event

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

Full Information

NCT ID

NCT04624646

First Posted

November 5, 2020

Last Updated

January 24, 2023

Sponsor

Ewha Womans University Mokdong Hospital

Collaborators

Korea Health Industry Development Institute

1. Study Identification

Unique Protocol Identification Number

NCT04624646

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2020 (Actual)

Primary Completion Date

September 18, 2024 (Anticipated)

Study Completion Date

September 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ewha Womans University Mokdong Hospital

Collaborators

Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack

Keywords

Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Conventional Holter Monitoring Group

Arm Type

Active Comparator

Arm 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.

Arm Title

Discontinuous Monitoring Group

Arm Type

Experimental

Arm Description

Arm Title

Single-lead Continuous Patch Group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Discontinuous monitoring

Intervention Description

Discontinuous ECG monitoring by finger contact every day

Intervention Type

Device

Intervention Name(s)

Continuous single-lead ECG Patch

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

24-hour Holter monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Atrial fibrillation detection rate

Description

Compare detection rates of each arms

Time Frame

Until 1 year after stroke

Secondary Outcome Measure Information:

Title

Recurrent stroke

Description

Recurrent stroke

Time Frame

Until 1 year after stroke

Title

Major adverse cardiac and cerebrovascular event

Description

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

Time Frame

Until 1 year after stroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junbeom Park, M.D.,PhD

Phone

+821035399822

parkjb@ewha.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Sodam Jung, M.D.

Phone

+821073209202

cvdosam@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Junbeom Park, M.D., PhD.

Organizational Affiliation

Ewha Womans University Mokdong Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tae-Jin Song, MD

Organizational Affiliation

Ewha Womans University Seoul Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dong-Hyeok Kim, MD

Organizational Affiliation

Ewha Womans University Seoul Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University Health System, Yongin Severance Hospital

City

Yongin

State/Province

Gyeonggi-do

ZIP/Postal Code

17046

Country

Korea, Republic of

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Professor

Facility Name

Ewha Womans University Seoul Hospital

City

Gangseo

State/Province

Seoul

ZIP/Postal Code

07985

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong-Hyeok Kim, MD

First Name & Middle Initial & Last Name & Degree

Dong-Hyeok Kim, MD

First Name & Middle Initial & Last Name & Degree

Tae-Jin Song, MD

Facility Name

Hanyang University Seoul Hospital

City

Seongdong

State/Province

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jinkyu Park, M.D.,PhD.

First Name & Middle Initial & Last Name & Degree

Jinkyu Park

Facility Name

Ewha Womans University Mokdong Hospital

City

Yangcheon

State/Province

Seoul

ZIP/Postal Code

07985

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suhe Kwon

Phone

+82 2-2650-5865

suhe_e@daum.net

First Name & Middle Initial & Last Name & Degree

Junbeom Park, MD

First Name & Middle Initial & Last Name & Degree

Yoonkyung Chang, MD

First Name & Middle Initial & Last Name & Degree

Sodam Jung, MD

Facility Name

Daegu Catholic University Medical Center

City

Daegu

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Young-Soo Lee, MD

First Name & Middle Initial & Last Name & Degree

Young-Soo Lee, MD

First Name & Middle Initial & Last Name & Degree

Jin Kuk Do, MD

Facility Name

Gachon University Gil Hospital

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye-min Park, MD

First Name & Middle Initial & Last Name & Degree

Ye-min Park, MD

Facility Name

Kyung Hee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jung Myung Lee, MD

Facility Name

Yonsei University Health System, Severance Hospital

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Young Dae Kim

First Name & Middle Initial & Last Name & Degree

Young Dae Kim, MD

First Name & Middle Initial & Last Name & Degree

Hyo Suk Nam, MD

First Name & Middle Initial & Last Name & Degree

Ji Hoe Heo, MD

First Name & Middle Initial & Last Name & Degree

Tae-Hoon Kim, MD

First Name & Middle Initial & Last Name & Degree

Hee Tae Yu, MD

Facility Name

Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung-Young Roh, MD

First Name & Middle Initial & Last Name & Degree

Seung-Young Roh, MD

First Name & Middle Initial & Last Name & Degree

Chi Kyung Kim, MD

12. IPD Sharing Statement

Learn more about this trial

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

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