Clinical Trials Logo

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)
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A