An observational study in Coronary Artery Disease (CAD), Artificial Intelligence Algorithms and Face, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by China National Center for Cardiovascular Diseases · Observational
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:
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.
Community high-risk population, defined as individuals meeting at least one of the following criteria:
Exclusion Criteria:
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.
Other: No Intervention
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.
Other: No Intervention
No Intervention
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.
Time frame: Up to 6 months
The detection rate of CAD
The detection rate of CAD
Time frame: 6 months
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.
Time frame: 6 months
Incidence of All-Cause Death
The number of participants who die from any cause during the follow-up period.
Time frame: 6 months
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).
Time frame: 6 months
Incidence of Ischemia-Driven Coronary Revascularization
Defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) driven by ischemic symptoms or objective evidence of ischemia.
Time frame: 6 months
Incidence of Screening-Driven Coronary Revascularization
Defined as coronary revascularization procedures (PCI or CABG) triggered by findings from screening examinations rather than acute clinical symptoms.
Time frame: 6 months
Plan to share: No
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China National Center for Cardiovascular Diseases