Prospective Multicenter Validation of a Home-Based AI-Enabled Single-Lead ECG for Detecting Low Ejection Fraction and Structural Heart Disease
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- National Defense Medical Center, Taiwan
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction
概览
简要总结
This prospective multicenter observational study will validate the accuracy of a previously developed artificial intelligence-enabled single-lead electrocardiogram (AI-ECG) model for identifying low heart pumping function and other structural heart disease phenotypes. Adult participants receiving a model-compatible single-lead ECG (Apple Watch and QOCA ECG102D) and transthoracic echocardiography at five hospitals in Taiwan will be enrolled between March 1, 2026 and June 30, 2026. AI model predictions will be compared with echocardiographic reference standards obtained after the index ECG within 30 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20 years or older
- •Single-lead ECG recorded using a study-compatible device
- •Ability to comply with study procedures and, when applicable, provide informed consent according to local IRB requirements
- •Without Transthoracic echocardiography within 90 days before the index ECG
排除标准
- •ECG signal quality insufficient for prespecified AI analysis
- •Without Transthoracic echocardiography available within 30 days after the index ECG
- •Echocardiography unavailable or technically inadequate for determining EF
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve for Detection of Low Left Ventricular Ejection Fraction
时间窗: 30 days
AUC with 95% confidence interval for detection of low EF, defined as echocardiographic LVEF ≤40%, by the pre-specified AI-enabled single-lead ECG model.
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value for Low EF Detection at the Pre-specified Operating Threshold
时间窗: 30 days
Diagnostic operating characteristics of the locked AI model for low EF at the pre-specified threshold.
次要结局
- Positive Predictive Value and Negative Predictive Value for Structure Heart Disease at the Pre-specified Operating Threshold(30 days)
- The Difference of Mortality Risk at the Pre-specified Operating Threshold(90 days)
研究者
Chin Lin
Professor
National Defense Medical Center, Taiwan