Coronary Artery DiseaseNCT03214783
A Case-control Study 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 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Facial characteristics
- How many people
- 2,300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 31 Oct 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who undergo coronary computer tomography or coronary angiography from both resident patients and outpatient.
Who may be able to join
- Undergoing coronary computer tomography or coronary angiography
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
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.
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, 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Facial characteristics
- Keywords
- artificial intelligence, facial recognition, facial characteristic
- 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.
Facial characteristicsOther
The exposures are facial characteristics which differ significantly in exposure rates between coronary artery disease (CAD) group and no CAD group.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease (CAD) group | Patients enrolled with at least one coronary lesion stenosis ≥50% according to coronary computer tomography or coronary angiography will be assigned to CAD group. Receives: Other: Facial characteristics | |
| No CAD group | Patients enrolled without coronary lesion stenosis ≥50% according to coronary computer tomography or coronary angiography will be assigned to CAD group. Receives: Other: Facial characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between facial factors and increased risk of coronary artery diseases
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 posted12 Jul 2017
- Study start10 Jul 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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.
- 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
- Retrospective
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214783
- Sponsor's protocol ID
- 2017-907
- Status last verified
- Nov 2018
- First submitted
- 8 Jul 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study to Assess the Association Between Facial Characteristics and Coronary Artery Diseases
- ClinicalTrials.gov ID
- NCT03214783
- Acronym / sponsor ID
- 2017-907
- Conditions
- Coronary Artery Disease
- Keywords
- artificial intelligence, facial recognition, facial characteristic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Jul 2017 (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 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.
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, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease (CAD) group | – | Other: Facial characteristicsPatients enrolled with at least one coronary lesion stenosis ≥50% according to coronary computer tomography or coronary angiography will be assigned to CAD group. |
| No CAD group | – | Other: Facial characteristicsPatients enrolled without coronary lesion stenosis ≥50% according to coronary computer tomography or coronary angiography will be assigned to CAD group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who undergo coronary computer tomography or coronary angiography from both resident patients and outpatient.
Key inclusion criteria (2 listed)
- Undergoing coronary computer tomography or coronary angiography
- Written informed consent
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Facial characteristicsThe exposures are facial characteristics which differ significantly in exposure rates between coronary artery disease (CAD) group and no CAD group. | Other | Coronary artery disease (CAD) group, No CAD group |
Primary outcome
The association between facial factors and increased risk of coronary artery diseases
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 6 Nov 2018.
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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.
1 site 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 1 site 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 5 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The association between facial factors and increased risk of coronary artery diseases (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 6 Nov 2018.