VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8,648
- 试验地点
- 1
- 主要终点
- Composite of Any Moderate or Severe VHD by Echocardiography
研究概览
简要总结
The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHD) in adults. The main question it aims to answer is:
．Can AI-ECG screening identify patients with significant heart valve diseases who may benefit from early echocardiography? Researchers will compare the rate of moderate or severe VHD detection between the experimental group and the control group to see if AI-ECG improve the detection rate of significant VHD.
Participants will:
- Be classified as high- or low-risk for VHD using an AI-ECG system
- In the experimental group, high-risk participants will receive echocardiography based on AI-ECG results
- In the control group, usual clinical care will be provided without routine echocardiography for AI-ECG high-risk results.
详细描述
This randomized controlled trial investigates the effectiveness of an artificial intelligence-powered electrocardiogram (AI-ECG) system for early screening of moderate or severe valvular heart disease (VHD) in adults receiving routine ECG examinations. The study population consists of adult outpatients undergoing a standard 12-lead ECG for any clinical indication. Each ECG is analyzed by a validated deep learning algorithm that automatically classifies the patient's risk for significant VHD.
Participants identified as high-risk by the AI-ECG system are randomized into either an experimental group or a control group. In the experimental group, high-risk participants undergo transthoracic echocardiography to confirm or exclude moderate or severe VHD. In the control group, high-risk participants continue with usual clinical care without additional echocardiographic screening based solely on the AI-ECG result. Low-risk participants in both groups receive routine care without additional intervention.
The primary aim is to determine whether AI-guided ECG screening, coupled with targeted echocardiography in the experimental group, increases the detection rate of clinically significant VHD compared to usual care. Secondary objectives include evaluating the impact on timely diagnosis, downstream clinical management, and the feasibility of integrating AI-ECG screening into routine outpatient workflows.
The study will follow participants for up to 90 days post-randomization to assess the detection rate and related outcomes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one 12-lead ECG within 1 year
- •Age 60-85 years of age
排除标准
- •Documented echocardiography within 3 years before indexed ECG
- •Any known valvular heart disease
- •History of any valvular surgery
- •Post-heart transplant
结局指标
主要结局
Composite of Any Moderate or Severe VHD by Echocardiography
时间窗: Within 90 days after randomization.
The composite endpoint is defined as detecting any moderate or severe VHD by echocardiography, including mitral regurgitation (MR), aortic regurgitation (AR), aortic stenosis (AS), and tricuspid regurgitation (TR).
次要结局
- Number of Participants with Moderate or Severe MR by Echocardiography(Within 90 days after randomization.)
- Number of Participants with Moderate or Severe AR by Echocardiography(Within 90 days after randomization.)
- Number of Participants with Moderate or Severe AS by Echocardiography(Within 90 days after randomization.)
- Number of Participants with Moderate or Severe TR by Echocardiography(Within 90 days after randomization.)
- Number of Participants with Other Cardiac Diseases by Echocardiography(Within 90 days after randomization.)
研究者
Yu-Lan Liu
Doctor of Medicine
National Defense Medical Center, Taiwan