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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03214783
Other study ID # 2017-907
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2017
Est. completion date October 31, 2018

Study information

Verified date November 2018
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the facial characteristics associated with the increased risk of coronary artery diseases. The secondary purpose is 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, we designed a case-control study to explore new, common and well-defined facial characteristics associated with CAD and evaluate the diagnostic efficacy of appearence factors in CAD. We will recuit 1150 patients with at least one coronary lesion stenosis ≥50% according to coronary angiography or coronary computer tomography (CAD group) and 1150 patients without coronary lesion stenosis≥ 50% (No CAD group) judged by coronary angiography or coronary computer tomography. We will collect patients' baseline information and facial images. One hand, we will explore the facial factors associated with CAD by comparing the exposure rates of different facial factors in CAD group and No CAD group based on artificial intelligence technology. On the other hand, we will build a CAD risk model based on facial factors, and evaluate the diagnostic effect of the model.


Recruitment information / eligibility

Status Completed
Enrollment 2300
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Undergoing coronary computer tomography or coronary angiography

- Written informed consent

Exclusion Criteria:

- Prior percutaneous coronary intervention (PCI)

- Prior coronary artery bypass graft (CABG)

- 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:
Facial characteristics
The exposures are facial characteristics which differ significantly in exposure rates between coronary artery disease (CAD) group and no CAD group.

Locations

Country Name City State
China Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases 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 The association between facial factors and increased risk of coronary artery diseases at the end of enrollment (6 months)
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