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

NCT07277686 | Recruiting

• 1 other identifier: 2025-ZX165
• Study Type: observational
• Target: 1,392
• Locations: 1 country
• Sites: 3

Brief 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. 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. 2.To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.

Conditions

Coronary Artery Disease (CAD); Artificial Intelligence Algorithms; Face; Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

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

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

Interventions

No Intervention OTHER

No Intervention

Diagnostic Test Cohort; Real-world Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine

Zhoukou, Henan, 466000, China

RECRUITING

Zhoukou Specialized Disease Hospital

Zhoukou, Henan, 466000, China

RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100037, China

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Facies

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zhe zheng, MD, PhD

CONTACT

+86-010-88398027; zhengzhe@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: December 11, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)