NCT03731936

Brief Summary

The purposes of this study are 1) to explore the association between facial characteristics and the increased risk of coronary artery diseases; 2) to evaluate the diagnostic efficacy of 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
6,864

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

9 active sites

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

Study Start

First participant enrolled

July 10, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

November 4, 2018

Last Update Submit

August 17, 2019

Conditions

Keywords

artificial intelligencefacial characteristics

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of diagnostic model

    The sensitivity of coronary artery diagnostic model assessed in model test group

    at the end of enrollment (6 months)

Secondary Outcomes (5)

  • Specificity of diagnostic model

    at the end of enrollment (6 months)

  • Specificity of diagnostic model

    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)

Model establishment and test group

Patients undergoing coronary angiography or coronary computer tomography angiography will be enrolled. Patients data will be used to establish the facial based diagnostic model of coronary artery diseases, and to prospectively validate the diagnostic effectiveness of the model.

Other: No intervention

Interventions

No intervention

Model establishment 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 (9)

Beijing Anzhen hospital

Beijing, Beijing Municipality, 100032, China

Location

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

Location

Guanganmen Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100032, China

Location

Wuhan union hospital

Wuhan, Hubei, 430000, China

Location

Xuzhou third people's hospital

Xuzhou, Jiangsu, 221000, China

Location

The first affiliated hospital of Dalian medical university

Dalian, Liangning, 116000, China

Location

Shanghai East hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Renji hospital

Shanghai, Shanghai Municipality, 200000, China

Location

The fisrt affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, 325000, 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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 6, 2018

Study Start

July 10, 2017

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations