Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
研究概览
简要总结
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Study design: This study is a cluster-randomized and controlled trial.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria.
Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Sample size: About 50 centers, at least 20,000 participants.
Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
详细描述
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Rationale: With the advancement of technology and the development of artificial intelligence, it has become possible to detect atrial fibrillation during routine blood pressure measurements. Previous studies have explored the accuracy of the blood pressure monitor for atrial fibrillation detection. However, the efficiency and adherence of using this device for large-scale population screening remain unknown.
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Study design: This study is a cluster-randomized and controlled trial. The eligible center as a cluster will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Inclusion criteria included: 1) Signed and dated informed consent form. 2) Age ≥ 60 years. 3) Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally. The only exclusion criteria is severe communication problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 125 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent form.
- •Age ≥ 60 years.
- •Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.
排除标准
- •Participants with severe communication problems.
研究组 & 干预措施
Single-lead ECG
干预措施: Single-lead ECG (Device)
Blood pressure monitor
干预措施: Blood pressure monitor (Device)
结局指标
主要结局
The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
时间窗: Baseline
次要结局
- The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.(Baseline)
研究者
Ji-Guang Wang
Director of the Shanghai Institute of Hypertension
Ruijin Hospital