NCT04941560

Brief Summary

The purposes of this study are 1) to explore the association between multi-dimension facial characteristics and the increased risk of coronary artery diseases (CAD); 2) to evaluate the diagnostic efficacy of multi-dimension appearance factors for coronary artery diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

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

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 6, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

June 22, 2021

Last Update Submit

March 17, 2023

Conditions

Keywords

Artificial intelligenceFacial characteristics

Outcome Measures

Primary Outcomes (1)

  • Area under receiver operating curve (AUC)

    Area under receiver operating curve of algorithm assessed in test group

    At the end of enrollment (1 mouth)

Secondary Outcomes (5)

  • Sensitivity of algorithm

    At the end of enrollment (1 mouth)

  • Specificity of algorithm

    At the end of enrollment (1 mouth)

  • Positive predictive value (PPV)

    At the end of enrollment (1 mouth)

  • Negative predictive value (NPV)

    At the end of enrollment (1 mouth)

  • Diagnostic accuracy rate

    At the end of enrollment (1 mouth)

Study Arms (1)

Algorithm training and test group

Patients undergoing coronary angiography or coronary computer tomography angiography will be enrolled. Patients data will be used to training and validate the algorithm for CAD detection based on facial photos.

Other: No intervention

Interventions

No intervention

Algorithm training and test group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo coronary angiography or coronary computer tomography angiography from both resident patients and outpatient.

You may qualify if:

  • Undergoing coronary angiography or coronary computer tomography angiography
  • Written informed consent

You may not qualify if:

  • Prior percutaneous coronary intervention (PCI)
  • Prior coronary artery bypass graft (CABG)
  • Screening coronary artery disease before treating other heart diseases
  • Without blood biochemistry outcome
  • 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)

Fuwai hospital

Beijing, Beijing Municipality, 100032, 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
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 28, 2021

Study Start

September 6, 2021

Primary Completion

February 10, 2023

Study Completion

February 10, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations