About this trial
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:
1. 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. 2. To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >= 18 years.
Diagnosed with Diabetes Mellitus;
Diagnosed with Hypertension;
Advanced age (> 65 years old).
Disqualifiers
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.
Trial population
The study population consists of community-dwelling residents identified as high-risk for Coronary Heart Disease (CHD). Participants are recruited from local community health centers and primary care settings. The cohort primarily comprises elderly individuals (aged \> 65 years) and those with established cardiovascular risk factors, specifically diabetes mellitus and hypertension, who have not been previously diagnosed with CHD.
Trial design
Cohort
Prospective
Treatments tested in this trial
No Intervention
Other interventionNo Intervention
Treatment groups
Trial outcomes
Primary outcomes
Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups
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.
Secondary outcomes
The detection rate of CAD
The detection rate of CAD
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite endpoint including all-cause death, myocardial infarction, and ischemia-driven coronary revascularization. The incidence of MACE will be compared between the diagnostic test cohort and the real-world observational cohort.
Incidence of All-Cause Death
The number of participants who die from any cause during the follow-up period.
Incidence of Myocardial Infarction
The number of participants who experience a myocardial infarction event, diagnosed based on standard clinical guidelines (e.g., symptoms, ECG changes, and troponin elevation).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
China National Center for Cardiovascular Diseases
Lead sponsor
Zhoukou Specialized Disease Hospital
Collaborator
Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Zhoukou Central Hospital
Collaborator