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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731936
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: No intervention

Detailed 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.

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Study Type : Observational
Actual Enrollment : 6864 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Artificial Intelligence to Assess the Association Between Facial Characteristics and Coronary Artery Diseases
Actual Study Start Date : July 10, 2017
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
No intervention




Primary Outcome Measures :
  1. Sensitivity of diagnostic model [ Time Frame: at the end of enrollment (6 months) ]
    The sensitivity of coronary artery diagnostic model assessed in model test group


Secondary Outcome Measures :
  1. Specificity of diagnostic model [ Time Frame: at the end of enrollment (6 months) ]
    The specificity of coronary artery diagnostic model assessed in model test group

  2. Specificity of diagnostic model [ Time Frame: at the end of enrollment (6 months) ]
    Area under receiver operating curve (AUC) of diagnostic model assessed in model test group

  3. Positive predictive value (PPV) [ Time Frame: at the end of enrollment (6 months) ]
    PPV of diagnostic model assessed in model test group

  4. Negative predictive value (NPV) [ Time Frame: at the end of enrollment (6 months) ]
    NPV of diagnostic model assessed in model test group

  5. Diagnostic accuracy rate [ Time Frame: at the end of enrollment (6 months) ]
    Diagnostic accuracy rate of diagnostic model assessed in model test group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo coronary angiography or coronary computer tomography angiography from both resident patients and outpatient.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731936


Locations
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China, Beijing
Beijing Anzhen hospital
Beijing, Beijing, China, 100032
Fuwai hospital
Beijing, Beijing, China, 100032
Guanganmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing, China, 100032
China, Hubei
Wuhan union hospital
Wuhan, Hubei, China, 430000
China, Jiangsu
Xuzhou third people's hospital
Xuzhou, Jiangsu, China, 221000
China, Liangning
The first affiliated hospital of Dalian medical university
Dalian, Liangning, China, 116000
China, Shanghai
Shanghai East hospital
Shanghai, Shanghai, China, 200000
Shanghai Renji hospital
Shanghai, Shanghai, China, 200000
China, Zhejiang
The fisrt affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
China National Center for Cardiovascular Diseases

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03731936    
Other Study ID Numbers: 20181104-2017-907
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
artificial intelligence
facial characteristics
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases