Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases

Coronary Artery Disease Clinical Trial

Official title:

Artificial Intelligence to Assess the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941560
• Other study ID #: 20210621-2021-1471
• Status: Completed
• Start date: September 6, 2021
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Previous study demonstrated the feasibility of using deep learning to detect coronary artery disease based on facial photos. However, several limitations made the algorithm hard to be utilized in clinical practice, including low specificity and lack of external validation. Adding multi-dimension facial characteristics may further increase the algorithm effect. Thus, the investigators designed a single-center, cross-sectional study to explore the association between multi-dimension facial characteristics and CAD and to evaluate the predictive efficacy of multi-dimension appearance factors for CAD. The investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. Patients' baseline information and multi-dimension facial images will be collected. The investigators will train and validate a deep learning algorithm based on multi-dimension facial photos.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity of algorithm	Sensitivity of algorithm assessed in test group	At the end of enrollment (1 mouth)
Secondary	Specificity of algorithm	Specificity of algorithm assessed in test group	At the end of enrollment (1 mouth)
Secondary	Positive predictive value (PPV)	PPV of algorithm assessed in test group	At the end of enrollment (1 mouth)
Secondary	Negative predictive value (NPV)	NPV of algorithm assessed in test group	At the end of enrollment (1 mouth)
Secondary	Diagnostic accuracy rate	Diagnostic accuracy rate of algorithm assessed in test group	At the end of enrollment (1 mouth)