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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03731936
Other study ID # 20181104-2017-907
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2017
Est. completion date August 2, 2019

Study information

Verified date August 2019
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Several age-related appearance factors were described associated with increased risk of coronary artery diseases (CAD). However, several limitations made these facial risk factors hard to be utilized in clinical practice, including 1) low prevalence in CAD patients, 2) lack of specific definition, 3) poor reproducibility in artificial recognition.

Thus, the investigators designed a multi-center, cross-sectional study to explore the association between facial characteristics and CAD and evaluate the diagnostic efficacy of appearance factors for CAD. The investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. Patients' baseline information and facial images will be collected. First, the investigators will explore the facial factors associated with CAD by using artificial intelligence technology to compare facial photographs between patients with CAD and without CAD. Secondary, the investigators will evaluate the dose-response relationship between facial characteristics and CAD. Third, the investigators will establish a CAD risk model based on facial factors, and evaluate the diagnostic effect of the model.


Recruitment information / eligibility

Status Completed
Enrollment 6864
Est. completion date August 2, 2019
Est. primary completion date August 2, 2019
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

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China Beijing Anzhen hospital Beijing Beijing
China Fuwai hospital Beijing Beijing
China Guanganmen Hospital, Chinese Academy of Traditional Chinese Medicine Beijing Beijing
China The first affiliated hospital of Dalian medical university Dalian Liangning
China Shanghai East hospital Shanghai Shanghai
China Shanghai Renji hospital Shanghai Shanghai
China The fisrt affiliated hospital of Wenzhou medical university Wenzhou Zhejiang
China Wuhan union hospital Wuhan Hubei
China Xuzhou third people's hospital Xuzhou Jiangsu

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 Sensitivity of diagnostic model The sensitivity of coronary artery diagnostic model assessed in model test group at the end of enrollment (6 months)
Secondary Specificity of diagnostic model The specificity of coronary artery diagnostic model assessed in model test group at the end of enrollment (6 months)
Secondary Specificity of diagnostic model Area under receiver operating curve (AUC) of diagnostic model assessed in model test group at the end of enrollment (6 months)
Secondary Positive predictive value (PPV) PPV of diagnostic model assessed in model test group at the end of enrollment (6 months)
Secondary Negative predictive value (NPV) NPV of diagnostic model assessed in model test group at the end of enrollment (6 months)
Secondary Diagnostic accuracy rate Diagnostic accuracy rate of diagnostic model assessed in model test group at the end of enrollment (6 months)
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