NCT06036342已完成不适用
Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Atrial fibrillation detection rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Atrial fibrillation detection rate
时间窗: 1 year
Atrial fibrillation detection rate at 1-year follow-up time
次要结局
- The detection rate of other arrhythmias(up to 7 days)
- Clinical outcome during 1-year follow-up.(1 year)
- Evaluation of the convenience of wearing and using the Mobicare device(up to 1 month)
- The detection rate of atrial fibrillation(up to 7 days)
- The burden of atrial fibrillation.(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)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital
研究点 (2)
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