A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension: 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
- 8,666
- 试验地点
- 1
- 主要终点
- Pulmonary arterial pressure > 50 mmHg
研究概览
简要总结
This study aims to validate the use of an artificial intelligence-enabled electrocardiogram (AI-ECG) to screen for elevated PAP. We hypothesize that the AI-ECG model can early identify patients with pulmonary hypertension in high-risk patients, prompting further evaluation through echocardiography, potentially resulting in improving cardiovascular outcomes.
详细描述
Pulmonary hypertension is often underdiagnosed due to extensive category of etiology. The diagnosis and treatment of pulmonary hypertension have changed dramatically through the re-defined diagnostic criteria and advanced drug development in the past decade. The application of Artificial Intelligence for the detection of elevated pulmonary arterial pressure (ePAP) was reported recently. An AI model based on electrocardiograms (ECG) has shown promise in not only detecting ePAP but also in predicting future risks related to cardiovascular mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, ≥ 50 to 85 years of age
- •At least one 12-lead ECG within 3 months
排除标准
- •A diagnosis of PH WHO Groups 1, 2, 3, 4, or 5
- •A diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- •Prior heart, lung, or heart-lung transplants
- •Any systolic pulmonary artery pressure >50 mmHg by echocardiography before
- •Echocardiography in 3 months before index ECG
研究组 & 干预措施
AI-ECG guidance
Participants in this arm undergo screening using the AI-ECG system. Those identified as high-risk for pulmonary hypertension receive echocardiography to confirm the diagnosis and guide subsequent management.
干预措施: AI-ECG Guidance (Diagnostic Test)
Standard clinical care
Participants in this arm are screened using the AI-ECG system, but diagnosis and management follow the usual clinical practice without echocardiography.
结局指标
主要结局
Pulmonary arterial pressure > 50 mmHg
时间窗: 90 days
The composite endpoint is defined as detecting pulmonary hypertension \> 50mmHg by echocardiography, indicating high risk for pulmonary hypertension.
次要结局
- Left atrial enlargement on a parasternal long axis view(Within 90 days after randomization.)
- Left atrial enlargement by left atrium volume index(Within 90 days after randomization.)
- Right ventricular enlargement on a parasternal long axis view(Within 90 days after randomization.)
- New onset of left ventricular dysfunction(Within 90 days after randomization.)
研究者
Pang-Yen, Liu
Assistant professor
National Defense Medical Center, Taiwan