Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

NCT06036342 | Active Not Recruiting

• 1 other identifier: AF-CARE
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation detection rate

  Atrial fibrillation detection rate at 1-year follow-up time

  1 year

Secondary Outcomes (6)

• The detection rate of atrial fibrillation

  up to 7 days

• The burden of atrial fibrillation.

  up to 7 days

• The detection rate of other arrhythmias

  up to 7 days

• The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control

  1 year

• Clinical outcome during 1-year follow-up.

  1 year

Interventions

MobiCARE test DIAGNOSTIC_TEST

7-days continuous electrocardiography monitoring using MobiCARE device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Those who have undergone a health screening examination.

You may qualify if:

• Subjects aged 65 years or older who have at least one stroke risk factor\*
• Subjects aged 19 years to \<65 years who have two or more stroke risk factors.
• 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

You may not qualify if:

• Subjects diagnosed with atrial fibrillation in the past
• Subjects aged under 19 years and other vulnerable research subjects
• Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously
• Subjects who have a structural abnormality in the thorax and is difficult to attach the device.
• Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator)
• Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening
• Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: September 13, 2023
• Study Start: April 25, 2022
• Primary Completion: December 10, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)