Clinical trial NCT06036342: Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
Official title: Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2023-09-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Those who have undergone a health screening examination.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Atrial fibrillation detection rate
timeFrame: 1 year
Secondary outcomes:
measure: The detection rate of atrial fibrillation
timeFrame: up to 7 days
measure: The burden of atrial fibrillation.
timeFrame: up to 7 days
measure: The detection rate of other arrhythmias
timeFrame: up to 7 days
measure: The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control
timeFrame: 1 year
measure: Clinical outcome during 1-year follow-up.
timeFrame: 1 year
measure: Evaluation of the convenience of wearing and using the Mobicare device
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: