AI Facial Analysis Algorithm to Screening Coronary Artery Disease in High-Risk Community Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,392
- 试验地点
- 3
- 主要终点
- Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups
研究概览
简要总结
This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are:
- To verify if the AI algorithm can accurately distinguish between high-risk and low-risk groups by comparing the actual prevalence of CAD in these groups.
- To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 years.
- •Community high-risk population, defined as individuals meeting at least one of the following criteria:
- •Diagnosed with Diabetes Mellitus;
- •Diagnosed with Hypertension;
- •Advanced age (> 65 years old).
排除标准
- •Prior confirmed diagnosis of Coronary Heart Disease (CAD), including clinically diagnosed CAD, history of Coronary Artery Bypass Grafting (CABG), or history of Percutaneous Coronary Intervention (PCI).
- •History of diagnosed Heart Failure.
- •Significant facial alterations or conditions that may interfere with AI image analysis, such as plastic surgery, severe facial trauma, or heavy makeup.
- •Refusal to participate in the study.
研究组 & 干预措施
Diagnostic Test Cohort
Participants in this cohort undergo facial image-based AI screening. Subsequently, all participants in this group will undergo Coronary Computed Tomography Angiography (CCTA) as the gold standard reference to verify the diagnosis of CAD. All participants are followed up for 6 months.
干预措施: No Intervention (Other)
Real-world Observational Cohort
Participants in this cohort represent a real-world setting. They are followed up for 6 months to observe the natural detection rate of CAD and the occurrence of MACE outcomes.
干预措施: No Intervention (Other)
结局指标
主要结局
Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups
时间窗: Up to 6 months
Participants in the diagnostic test cohort are stratified into high-risk and low-risk groups using the AI screening strategy. Subsequently, all participants undergo Coronary Computed Tomography Angiography (CCTA). This outcome measures the difference in CAD prevalence between the two groups based on CCTA results.
次要结局
- The detection rate of CAD(6 months)
- Incidence of Major Adverse Cardiovascular Events (MACE)(6 months)
- Incidence of All-Cause Death(6 months)
- Incidence of Myocardial Infarction(6 months)
- Incidence of Ischemia-Driven Coronary Revascularization(6 months)
- Incidence of Screening-Driven Coronary Revascularization(6 months)