Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

Atrial Fibrillation Clinical Trial

Official title:

Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036342
• Other study ID #: AF-CARE
• Status: Recruiting
• Start date: April 25, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Seoul National University Hospital
• Contact: Eue-Keun Choi, M.D. Ph.D.
• Phone: 82-2-2072-0688
• Email: choiek417[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to detect and diagnose atrial fibrillation early by conducting a screening test for atrial fibrillation using a continuous electrocardiography monitoring device for those who have undergone a health screening examination.

Early detection through atrial fibrillation screening tests in high-risk patients with stroke is intended to prevent stroke by starting stroke prevention treatment early. It is intended to detect asymptomatic atrial fibrillation patients early through examination and ultimately improve the quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Subjects aged 65 years or older who have at least one stroke risk factor*

2. Subjects aged 19 years to <65 years who have two or more stroke risk factors.

3. Subjects aged 75 years or older

• Stroke risk factors: heart failure, hypertension, diabetes, vascular disease, women, stroke/systemic embolism/transient ischemic attack (although stroke/systemic embolism/transient ischemic attack among stroke risk factors is considered to have two risk factors)

• Heart failure: a history of heart failure diagnosis or a history of current heart failure treatment.

• Hypertension, Diabetes: Diagnostic History

• Vascular diseases: Significant coronal atherosclerosis (when 70% or more of the computed tomography or coronary angiography is present or coronary intervention is performed), 50% or more of the carotid artery disease, peripheral vascular disease, history of myocardial infarction, and aortic plaques

Exclusion Criteria:

1. Subjects diagnosed with atrial fibrillation in the past

2. Subjects aged under 19 years and other vulnerable research subjects

3. Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously

4. Subjects who have a structural abnormality in the thorax and is difficult to attach the device.

5. Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator)

6. Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening

7. Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• MobiCARE test
7-days continuous electrocardiography monitoring using MobiCARE device

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation detection rate	Atrial fibrillation detection rate at 1-year follow-up time	1 year
Secondary	The detection rate of atrial fibrillation	The detection rate of atrial fibrillation	up to 7 days
Secondary	The burden of atrial fibrillation.	The burden of atrial fibrillation.	up to 7 days
Secondary	The detection rate of other arrhythmias	The detection rate of other arrhythmias in addition to atrial fibrillation	up to 7 days
Secondary	The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control	The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control at 1-year follow-up time	1 year
Secondary	Clinical outcome during 1-year follow-up.	stroke, transient ischemic attack, systemic embolism, admission for heart failure, admission for atrial fibrillation manage/control, cardiac arrest, cardiovascular death, and all-cause death	1 year
Secondary	Evaluation of the convenience of wearing and using the Mobicare device	Questionnaire about convenience of wearing and using the Mobicare device; Did you feel uncomfortable going about your daily routine, and mainly when?; If you felt uncomfortable, what were your main concerns?; If your skin itches or breaks out in a rash during use, how long has it been since you've been wearing it?; How much discomfort did you experience due to foreign body sensation, skin problems, etc.?; Has your device ever been dropped while in use? If so, when did it happen?; Were there any challenges in reattaching the device, and if so, what were they?; How often have you taken your device off and put it back on?; How long do you think you can run the test without too much inconvenience?	up to 1 month