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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease (CAD); Screening; Face; Artificial Intelligence Algorithms
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 1392

Contacts and Locations

• Study Contact: Name: zhe zheng, MD, PhD; Phone Number: +86-010-88398027; Email: zhengzhe@fuwai.com

Study Locations

• China
  • Beijing, China, 100037
    • Not yet recruiting
    • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: zhe zheng, MD, PhD; Phone Number: +86-010-88398027; Email: zhengzhe@fuwai.com
  • Henan
    • Zhoukou, Henan, China, 466000
      • Recruiting
      • Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine
      • Contact: Hui An; Email: crz779@163.com
    • Zhoukou, Henan, China, 466000
      • Recruiting
      • Zhoukou Specialized Disease Hospital
      • Contact: Yujie Bai; Phone Number: +86-13393946520; Email: crz0604@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No Intervention; No Intervention
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.	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Incidence of All-Cause Death	The number of participants who die from any cause during the follow-up period.	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).	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.	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.	6 months
The detection rate of CAD	The detection rate of CAD	6 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Zhoukou Central Hospital; Zhoukou Specialized Disease Hospital; Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Estimated): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Coronary Artery Disease; Facies
• Other Study ID Numbers: 2025-ZX165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No