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NCT Number: NCT07277686

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Artificial Intelligence Algorithms Cardiovascular Diseases Coronary Artery Disease Coronary Disease Disease Attributes Face Facies Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Screening Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine, Zhoukou, Henan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

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.

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

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

    Time frame: 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

  1. The detection rate of CAD

    Time frame: 6 months

    The detection rate of CAD

  2. Incidence of Major Adverse Cardiovascular Events (MACE)

    Time frame: 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.

  3. Incidence of All-Cause Death

    Time frame: 6 months

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

  4. Incidence of Myocardial Infarction

    Time frame: 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).

  5. Incidence of Ischemia-Driven Coronary Revascularization

    Time frame: 6 months

    Defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) driven by ischemic symptoms or objective evidence of ischemia.

  6. Incidence of Screening-Driven Coronary Revascularization

    Time frame: 6 months

    Defined as coronary revascularization procedures (PCI or CABG) triggered by findings from screening examinations rather than acute clinical symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

zhe zheng, MD, PhD

CONTACT

[email protected]

+86-010-88398027

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital
  • Zhoukou Central Hospital
  • Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine
  • Zhoukou Specialized Disease Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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