NCT06102226

Brief Summary

Artificial Intelligence, trained through model learning, can quickly perform medical image recognition and is widely used in early disease screening and assisted diagnosis. With the continuous optimization of deep learning, the application of AI has helped to discover some previously unknown associations with other systemic diseases. Artificial intelligence based on retinal fundus images can be used to detect anemia, hepatobiliary diseases, and chronic kidney disease, and to predict other systemic biomarkers. The above studies provide a theoretical basis for the application of artificial intelligence technology based on retinal fundus images to the diagnosis and prediction of cardiovascular diseases. At present, there is still a lack of accurate, rapid, and easy-to-use diagnostic and therapeutic tools for predictive modeling of coronary heart disease risk and early screening tools in China and the world. Fundus image is gradually used as a tool for extensive screening of diseases due to its special connection with blood vessels throughout the body, as well as easy access, cheap and efficient. It is of great scientific and social significance to develop and validate a model for identification and prediction of coronary heart disease and its risk factors based on fundus images using AI deep learning algorithms, and to explore the value of AI fundus images in assisting coronary heart disease diagnosis and screening for a wide range of applications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

October 22, 2023

Last Update Submit

October 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • AUC

    To evaluate the algorithm performance area under the receiver operating characteristic curve (AUC) were calculated

    December 30, 2024

Secondary Outcomes (2)

  • sensitivity

    December 30, 2024

  • specificity

    December 30, 2024

Study Arms (1)

coronary artery disease group / non- coronary artery disease group

Recruited patients were categorized into a coronary artery disease group and a non-coronary artery disease group on the basis of coronary angiography findings, and the presence of CAD was defined as the presence of a coronary artery lesion with a stenosis

Diagnostic Test: coronary artery imaging (coronary CTA or coronary angiography)

Interventions

In order to obtain the gold standard labeling for coronary heart disease, this topic will form a panel of experts on labeling, and the diagnosis will be based on coronary angiography, defined as a lesion with a stenosis of at least 50% in at least one coronary artery

coronary artery disease group / non- coronary artery disease group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible participants were ≥ 18 years of age, with clinically suspected CAD, and were scheduled for coronary angiography

You may qualify if:

  • Eligible participants were ≥ 18 years of age, with clinically suspected CAD, and were scheduled for coronary angiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yong Zeng

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

  • Ye Y, Feng W, Ding Y, Chen Q, Zhang Y, Lin L, Xia P, Ma T, Ju L, Wang B, Chang X, Wang X, Cai L, Ge Z, Zeng Y. Retinal image-based deep learning for mild cognitive impairment detection in coronary artery disease population. Heart. 2025 Oct 14;111(21):1013-1019. doi: 10.1136/heartjnl-2024-325486.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Officials

  • Yong Zeng

    Beijing An Zhen Hospital: Capital Medical University Affiliated Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Beijing Anzhen Hospital

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

July 1, 2021

Primary Completion

August 1, 2024

Study Completion

December 30, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations