Deep Learning Algorithm for Detecting Obstructive Coronary Artery Disease Using Fundus Photographs

Sponsor
Yong Zeng (Other)
Overall Status
Recruiting
CT.gov ID
NCT06102226
Collaborator
(none)
7,000
1
42
166.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: coronary artery imaging (coronary CTA or coronary angiography)

Study Design

Study Type:
Observational
Anticipated Enrollment :
7000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Deep Learning Algorithm for Detecting Obstructive Coronary Artery Disease Using Fundus Photographs
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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)
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

Outcome Measures

Primary Outcome Measures

  1. AUC [December 30, 2024]

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

Secondary Outcome Measures

  1. sensitivity [December 30, 2024]

    To evaluate the algorithm performance, the sensitivity were calculated

  2. specificity [December 30, 2024]

    To evaluate the algorithm performance, the specificity were calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:

The exclusion criteria were as follows: (i) prior percutaneous coronary intervention (PCI); (ii) prior coronary artery bypass graft (CABG); (iii) other heart disease (e.g., congenital heart disease, valvular heart disease, or macrovascular disease); (iv) inability to have photographs taken; and (v) and a diagnosis of ST-segment elevation myocardial infarction (STEMI). Prior to the coronary angiography procedure, all eligible patients provided informed consent to participate in the study and to have their photographs used for research purposes.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yong Zeng Beijing 北京 China 100029

Sponsors and Collaborators

  • Yong Zeng

Investigators

  • Principal Investigator: Yong Zeng, Beijing An Zhen Hospital: Capital Medical University Affiliated Anzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yong Zeng, Beijing Anzhen Hospital, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT06102226
Other Study ID Numbers:
  • 121100004006885458
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2023