ClinicalTrials.gg
RecruitingNCT07277686Updated Jan 6, 2026

AI Facial Analysis Algorithm to Screening Coronary Artery Disease in High-Risk Community Population

An observational study in Coronary Artery Disease (CAD), Artificial Intelligence Algorithms and Face, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,392
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases — 26 open to participants now, 27 under way, none of them phase 3. Coronary Artery Disease · China National Center for Cardiovascular Diseases.

Planned enrollment
7th of 25
1,392 · median 460
Started
2025
with 9 others
Observational
25 of 57
9 open now
Primary completion
2026-04
later than 4 of 26 live
Registered
45th of 57
by date

Among the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, this one is the 7th largest by planned enrollment of the 25 observational ones that give a count, is one of 10 that started in 2025, is one of 25 observational ones, reaches primary completion later than 4 of the 26 other live ones, and was the 45th registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

26 of the 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases are open now, in 1 country. Recruiting first, the newest first:

20 more — sign in →

By country, each count listing its studies:

All 26 open studies →

Where they have run

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 57 studies in Coronary Artery Disease by China National Center for Cardiovascular Diseases, or all of them as a file.
02

Study 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. 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.
  2. To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
03

Conditions studied

  • Coronary Artery Disease (CAD)
  • Artificial Intelligence Algorithms
  • Face
  • Screening
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >= 18 years.
  • Community high-risk population, defined as individuals meeting at least one of the following criteria:

    1. Diagnosed with Diabetes Mellitus;
    2. Diagnosed with Hypertension;
    3. Advanced age (> 65 years old).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,392 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months

Secondary outcomes

  1. The detection rate of CAD

    The detection rate of CAD

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. Incidence of All-Cause Death

    The number of participants who die from any cause during the follow-up period.

    Time frame: 6 months

  4. 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).

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

  6. 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.

    Time frame: 6 months

07

Study locations

2 of 3 sites recruiting
  • Zhoukou Chuanhui District Hospital of Traditional Chinese Medicine
    Zhoukou, Henan 466000, China
    Recruiting
  • Zhoukou Specialized Disease Hospital
    Zhoukou, Henan 466000, China
    Recruiting
  • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, 100037, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Apr 2026, 3 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 3 months is below that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2025
First posted
Dec 11, 2025
StartActual
Dec 11, 2025
Primary completionEst.
Apr 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07277686
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
First posted
Dec 11, 2025
Start date
Dec 11, 2025
Primary completion
Apr 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jan 6, 2026

Study contacts

zhe zheng, MD, PhD
Contact
zhengzhe@fuwai.com
+86-010-88398027

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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