Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Number of participates with AF episodes identified using continuous ECG monitoring compared to routine practice.
研究概览
简要总结
Atrial fibrillation(AF) can be asymptomatic and thus left unidentified in many people, but holds potential risk of lethal complications such as stroke and congestive heart failure. With different screening strategy, the screening result will be different. The longer the monitoring period is, the higher chances AF episodes can be identified, but with greater cost and lower compliance. Therefore, in this study, the investigators want to find the most cost-effective method for AF screening in high risk population with prolonged continuous single-lead ECG device.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age between 18-85 2.Score ≥5points in the above scoring system 3.Volunteer to participate in the study
排除标准
- •1.Clear history of atrial flutter or atrial fibrillation 2.History of pacemaker implacement 3.Already on anticoagulation therapy 4.History of severe contact dermatitis 5.ECG recorded by our device unrecognizable 6.Patients with end-stage disease or at advanced stage of cancer with life expectancy less than 1 year
结局指标
主要结局
Number of participates with AF episodes identified using continuous ECG monitoring compared to routine practice.
时间窗: 2020-2023
Some atrial fibrillation patients may be left undiagnosed by routine practice due to several reasons. On ECG, AF episodes are defined as irregularly irregular QRS complex with disappearance of P wave that last over 30 seconds. A routine ECG examination may not able to capture AF episodes, however, by monitoring the subjects' cardiac rhythm continuously for a prolonged time period, we can detect asymptomatic AF episodes with higher sensitivity that would have been missed. And by further analyzing the detection rates of different monitoring periods, we can find out the most cost-effective monitoring duration and pattern.
次要结局
未报告次要终点
研究者
Xiufang Gao
Associate chief physian
Huashan Hospital