Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

Seoul National University

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: MobiCARE test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06036342

AF-CARE

Details and patient eligibility

About

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.

Enrollment: 3,000 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.