AI Facial Analysis Algorithm to Screening Coronary Artery Disease in High-Risk Community Population

NCT07277686 — Recruiting, 1392 participants, China National Center for Cardiovascular Diseases

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Registry	NCT07277686
Status	Recruiting
Study type	Observational
Enrollment	1392 (Estimated)
Sponsor	China National Center for Cardiovascular Diseases (Other gov); collaborators: Zhoukou Specialized Disease Hospital, Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Zhoukou Central Hospital
Conditions	Coronary Artery Disease (CAD), Artificial Intelligence Algorithms, Face, Screening
Interventions	No Intervention (Other)
Dates	start 2025-12-11, primary completion 2026-04-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-12-11, last updated 2026-01-06
Locations	3 sites in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Diagnostic Test Cohort		Other: No Intervention	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.
Real-world Observational Cohort		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.

No Intervention (Other): No Intervention

+Outcome measures

Primary outcomes

Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups [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.

Secondary outcomes

The detection rate of CAD [6 months]: The detection rate of CAD
Incidence of Major Adverse Cardiovascular Events (MACE) [6 months]: 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 [6 months]: The number of participants who die from any cause during the follow-up period.
Incidence of Myocardial Infarction [6 months]: The number of participants who experience a myocardial infarction event, diagnosed based on standard clinical guidelines (e.g., symptoms, ECG changes, and troponin elevation).
Incidence of Ischemia-Driven Coronary Revascularization [6 months]: Defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) driven by ischemic symptoms or objective evidence of ischemia.
Incidence of Screening-Driven Coronary Revascularization [6 months]: Defined as coronary revascularization procedures (PCI or CABG) triggered by findings from screening examinations rather than acute clinical symptoms.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Age >= 18 years.
* Community high-risk population, defined as individuals meeting at least one of the following criteria:

  1. Diagnosed with Diabetes Mellitus;
  2. Diagnosed with Hypertension;
  3. Advanced age (> 65 years old).

Exclusion Criteria:

* 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.

+Locations (3)

Facility	City	Country	Status
Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine	Zhoukou, Henan	China	Recruiting
Zhoukou Specialized Disease Hospital	Zhoukou, Henan	China	Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	China	Not yet recruiting

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