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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No Intervention

Treatment groups

1,392 Participants
are divided into 2 treatment groups
Group A: Diagnostic Test Cohort1 intervention
Group B: Real-world Observational Cohort1 intervention

Trial outcomes

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.

Time frame
Up to 6 months

Secondary outcomes

1

The detection rate of CAD

The detection rate of CAD

Time frame
6 months
2

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
3

Incidence of All-Cause Death

The number of participants who die from any cause during the follow-up period.

Time frame
6 months
4

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

Other outcomes

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