NCT06850233

Brief Summary

The purpose of this study is to evaluate the effectiveness of a coronary heart disease screening algorithm based on facial photos in community population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

February 21, 2025

Last Update Submit

December 3, 2025

Conditions

Coronary Artery Disease

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of the algorithm

    The sensitivity of the CAD screening algorithm assessed in the group

    at the end of enrollment (6 months)

  • Specificity of the algorithm

    The specificity of the CAD screening algorithm assessed in the group

    at the end of enrollment (6 months)

Secondary Outcomes (4)

  • Discriminative capabilities

    at the end of enrollment (6 months)

  • Positive predictive value (PPV)

    at the end of enrollment (6 months)

  • Negative predictive value (NPV)

    at the end of enrollment (6 months)

  • Diagnostic accuracy rate

    at the end of enrollment (6 months)

Study Arms (1)

Algorithm external validation group

Other: No intervention

Interventions

No interventionOTHER

No intervention

Algorithm external validation group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Community population with a pre-test probability greater than 5% for coronary artery disease

You may not qualify if:

  • Prior percutaneous coronary intervention (PCI)
  • Prior coronary artery bypass graft (CABG)
  • The history of heart failure
  • With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
  • Other situations which make patients fail to be photographed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Road Community Health Service Center

Zhoukou, Henan, 466099, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

February 27, 2025

Study Start

March 4, 2025

Primary Completion

June 24, 2025

Study Completion

June 24, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

CN(1)