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

NCT ID: NCT07277686

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1392 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-11

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease (CAD) Artificial Intelligence Algorithms Face Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type 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.

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhoukou Specialized Disease Hospital

UNKNOWN

Sponsor Role collaborator

Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Zhoukou Central Hospital

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine

Zhoukou, Henan, China

Site Status RECRUITING

Zhoukou Specialized Disease Hospital

Zhoukou, Henan, China

Site Status RECRUITING

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

Beijing, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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zhe zheng, MD, PhD

Role: CONTACT

+86-010-88398027

Facility Contacts

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Hui An

Role: primary

Yujie Bai

Role: primary

+86-13393946520

zhe zheng, MD, PhD

Role: primary

+86-010-88398027

Other Identifiers

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2025-ZX165

Identifier Type: -

Identifier Source: org_study_id

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