Coronary Artery DiseaseNCT03731936
Artificial Intelligence to Assess the Association Between Facial Characteristics and Coronary Artery Diseases
An observational study of Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 6,864 participants
- Where
- 9 sitesChina
- Study dates
- 10 Jul 2017to 2 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who undergo coronary angiography or coronary computer tomography angiography from both resident patients and outpatient.
Who may be able to join
- Undergoing coronary angiography or coronary computer tomography angiography
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Anzhen hospital
Beijing, Beijing Municipality, 100032
Fuwai hospital
Beijing, Beijing Municipality, 100032
Guanganmen Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100032
The first affiliated hospital of Dalian medical university
Dalian, Liangning, 116000
Shanghai East hospital
Shanghai, Shanghai Municipality, 200000
Shanghai Renji hospital
Shanghai, Shanghai Municipality, 200000
The fisrt affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, 325000
Wuhan union hospital
Wuhan, Hubei, 430000
Xuzhou third people's hospital
Xuzhou, Jiangsu, 221000
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- No intervention
- Keywords
- artificial intelligence, facial characteristics
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of diagnostic model
The sensitivity of coronary artery diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Secondary outcomes (5)
Specificity of diagnostic model
The specificity of coronary artery diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Specificity of diagnostic model
Area under receiver operating curve (AUC) of diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Positive predictive value (PPV)
PPV of diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Negative predictive value (NPV)
NPV of diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Diagnostic accuracy rate
Diagnostic accuracy rate of diagnostic model assessed in model test group
Measured: at the end of enrollment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start10 Jul 2017
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6,864 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731936
- Sponsor's protocol ID
- 20181104-2017-907
- Status last verified
- Aug 2019
- First submitted
- 4 Nov 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence to Assess the Association Between Facial Characteristics and Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT03731936
- Acronym / sponsor ID
- 20181104-2017-907
- Conditions
- Coronary Artery Disease
- Keywords
- artificial intelligence, facial characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,864 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Model establishment and test group | – | Other: No interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo coronary angiography or coronary computer tomography angiography from both resident patients and outpatient.
Key inclusion criteria (2 listed)
- Undergoing coronary angiography or coronary computer tomography angiography
- Written informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Model establishment and test group |
Primary outcome
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
5 secondary outcomes
Specificity of diagnostic model
Time frame: at the end of enrollment (6 months)
Specificity of diagnostic model
Time frame: at the end of enrollment (6 months)
Positive predictive value (PPV)
Time frame: at the end of enrollment (6 months)
Negative predictive value (NPV)
Time frame: at the end of enrollment (6 months)
Diagnostic accuracy rate
Time frame: at the end of enrollment (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of diagnostic model (time frame: at the end of enrollment (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.