Coronary Artery Disease (CAD)NCT07277686
AI Facial Analysis Algorithm to Screening Coronary Artery Disease in High-Risk Community Population
An observational study of Coronary Artery Disease (CAD) and Artificial Intelligence Algorithms, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are: 1. 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 (CAD), Artificial Intelligence Algorithms, Face
- How many people
- 1,392 participants
- Where
- 3 sitesChina
- Study dates
- 11 Dec 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of community-dwelling residents identified as high-risk for Coronary Heart Disease (CHD). Participants are recruited from local community health centers and primary care settings. The cohort primarily comprises elderly individuals (aged > 65 years) and those with established cardiovascular risk factors, specifically diabetes mellitus and hypertension, who have not been previously diagnosed with CHD.
Who may be able to join
- Age >= 18 years.
- Community high-risk population, defined as individuals meeting at least one of the following criteria:
- Diagnosed with Diabetes Mellitus;
- Diagnosed with Hypertension;
- Advanced age (> 65 years old).
Who cannot join
- Prior confirmed diagnosis of Coronary Heart Disease (CAD), including clinically diagnosed CAD, history of Coronary Artery Bypass Grafting (CABG), or history of Percutaneous Coronary Intervention (PCI).
- History of diagnosed Heart Failure.
- Significant facial alterations or conditions that may interfere with AI image analysis, such as plastic surgery, severe facial trauma, or heavy makeup.
- Refusal to participate in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
zhe zheng, MD, PhD, +86-010-88398027, zhengzhe@fuwai.com
- Recruiting
Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine
Zhoukou, Henan, 466000
Hui An, crz779@163.com
- Recruiting
Zhoukou Specialized Disease Hospital
Zhoukou, Henan, 466000
Yujie Bai, +86-13393946520, crz0604@126.com
About this study
This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are:
- To verify if the AI algorithm can accurately distinguish between high-risk and low-risk groups by comparing the actual prevalence of CAD in these groups.
- To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
- Being tested
- No Intervention
- Medical subject headings
- Coronary Artery Disease, Facies
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 |
|---|---|---|
| Diagnostic Test Cohort | Participants in this cohort undergo facial image-based AI screening. Subsequently, all participants in this group will undergo Coronary Computed Tomography Angiography (CCTA) as the gold standard reference to verify the diagnosis of CAD. All participants are followed up for 6 months. Receives: Other: No Intervention | |
| Real-world Observational Cohort | Participants in this cohort represent a real-world setting. They are followed up for 6 months to observe the natural detection rate of CAD and the occurrence of MACE outcomes. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups
Participants in the diagnostic test cohort are stratified into high-risk and low-risk groups using the AI screening strategy. Subsequently, all participants undergo Coronary Computed Tomography Angiography (CCTA). This outcome measures the difference in CAD prevalence between the two groups based on CCTA results.
Measured: Up to 6 months
Secondary outcomes (6)
The detection rate of CAD
The detection rate of CAD
Measured: 6 months
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite endpoint including all-cause death, myocardial infarction, and ischemia-driven coronary revascularization. The incidence of MACE will be compared between the diagnostic test cohort and the real-world observational cohort.
Measured: 6 months
Incidence of All-Cause Death
The number of participants who die from any cause during the follow-up period.
Measured: 6 months
Incidence of Myocardial Infarction
The number of participants who experience a myocardial infarction event, diagnosed based on standard clinical guidelines (e.g., symptoms, ECG changes, and troponin elevation).
Measured: 6 months
Incidence of Ischemia-Driven Coronary Revascularization
Defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) driven by ischemic symptoms or objective evidence of ischemia.
Measured: 6 months
Incidence of Screening-Driven Coronary Revascularization
Defined as coronary revascularization procedures (PCI or CABG) triggered by findings from screening examinations rather than acute clinical symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start11 Dec 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Zhoukou Specialized Disease Hospital, Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Zhoukou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277686
- Sponsor's protocol ID
- 2025-ZX165
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Facial Analysis Algorithm to Screening Coronary Artery Disease in High-Risk Community Population
- ClinicalTrials.gov ID
- NCT07277686
- Acronym / sponsor ID
- 2025-ZX165
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,392 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Zhoukou Specialized Disease Hospital, Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine, Chinese Academy of Medical Sciences, Fuwai Hospital, Zhoukou Central Hospital
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 11 Dec 2025 (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.
This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are:
- To verify if the AI algorithm can accurately distinguish between high-risk and low-risk groups by comparing the actual prevalence of CAD in these groups.
- To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test Cohort | – | Other: No InterventionParticipants in this cohort undergo facial image-based AI screening. Subsequently, all participants in this group will undergo Coronary Computed Tomography Angiography (CCTA) as the gold standard reference to verify the diagnosis of CAD. All participants are followed up for 6 months. |
| Real-world Observational Cohort | – | Other: No InterventionParticipants in this cohort represent a real-world setting. They are followed up for 6 months to observe the natural detection rate of CAD and the occurrence of MACE outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of community-dwelling residents identified as high-risk for Coronary Heart Disease (CHD). Participants are recruited from local community health centers and primary care settings. The cohort primarily comprises elderly individuals (aged > 65 years) and those with established cardiovascular risk factors, specifically diabetes mellitus and hypertension, who have not been previously diagnosed with CHD.
Key inclusion criteria (5 listed)
- Age >= 18 years.
- Community high-risk population, defined as individuals meeting at least one of the following criteria:
Key exclusion criteria (4 listed)
- Prior confirmed diagnosis of Coronary Heart Disease (CAD), including clinically diagnosed CAD, history of Coronary Artery Bypass Grafting (CABG), or history of Percutaneous Coronary Intervention (PCI).
- History of diagnosed Heart Failure.
- Significant facial alterations or conditions that may interfere with AI image analysis, such as plastic surgery, severe facial trauma, or heavy makeup.
- Refusal to participate in the study.
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 | Diagnostic Test Cohort, Real-world Observational Cohort |
Primary outcome
Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups
Time frame: Up to 6 months
Participants in the diagnostic test cohort are stratified into high-risk and low-risk groups using the AI screening strategy. Subsequently, all participants undergo Coronary Computed Tomography Angiography (CCTA). This outcome measures the difference in CAD prevalence between the two groups based on CCTA results.
6 secondary outcomes
The detection rate of CAD
Time frame: 6 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 6 months
Incidence of All-Cause Death
Time frame: 6 months
Incidence of Myocardial Infarction
Time frame: 6 months
Incidence of Ischemia-Driven Coronary Revascularization
Time frame: 6 months
Incidence of Screening-Driven Coronary Revascularization
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
3 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 (CAD) and Artificial Intelligence Algorithms, run by China National Center for Cardiovascular Diseases at 3 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhe zheng, MD, PhD (+86-010-88398027, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Prevalence of CAD Between AI-Stratified High-Risk and Low-Risk Groups (time frame: Up to 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 Jan 2026.