Identification for High Risk of Coronary Heart Disease Based on Quantitative Analysis of Fundus Vessels and Metabolic Molecules

This ambidirectional observational cohort study builds upon and expands an existing coronary artery disease (CAD) cohort based on retinal fundus imaging (ChiCTR2200066429). A comprehensive baseline database will be established, including demographic characteristics, laboratory test results, coronary angiography findings, quantitative retinal vascular features, and multi-omics data.Artificial intelligence methods will be used to quantify retinal vascular characteristics and to develop and validate models for identifying and predicting CAD. In addition, targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays will be developed to measure previously identified CAD-related biomarkers, including metabolites and lipids, in baseline biological samples. Clinical, retinal imaging, and multi-omics data will subsequently be integrated to develop a risk stratification model for identifying individuals at high risk of CAD. Participants will be followed for cardiovascular events to evaluate the predictive performance of the model. The findings may support the development of improved strategies for CAD detection, risk assessment, and clinical management. No treatment or clinical intervention is assigned by the study protocol, and all medical decisions are made as part of routine clinical care.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

Detailed Description

This study uses an ambidirectional cohort design comprising both retrospective and prospective phases. The retrospective phase includes eligible participants identified from clinical records between June 01, 2022 and May 13, 2024. The prospective phase includes participants enrolled between May 14, 2024 and December 31, 2026, with follow-up for cardiovascular events.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Beijing Hospital
      • Contact: Xue Yu, Chief Physician; Phone Number: 010-85136132; Email: yuxuemd@aliyun.com
    • Beijing, Beijing Municipality, China, 100032
      • Not yet recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Hui Chen, Chief Physician; Phone Number: 010-63016616; Email: yuxuemd@aliyun.com
    • Beijing, Beijing Municipality, China, 100086
      • Completed
      • Beijing Haidian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of inpatients recruited from Beijing Hospital, Beijing Haidian Hospital, and Beijing Friendship Hospital, Capital Medical University. Eligible participants are adults older than 18 years who provide informed consent and undergo coronary angiography during hospitalization because of symptoms suggestive of myocardial ischemia or the presence of multiple cardiovascular risk factors. This study builds upon and further expands an existing coronary artery disease (CAD) cohort based on retinal fundus imaging (ChiCTR2200066429), which began enrolling participants in June 2022.

Description

Inclusion Criteria:

• Older than 18 years
• Symptoms suggestive of myocardial ischemia or the presence of multiple cardiovascular disease risk factors
• Underwent coronary angiography during hospitalization
• Underwent blood sample collection during hospitalization
• Underwent bilateral color fundus photography during hospitalization
• Availability of complete clinical data

Exclusion Criteria:

• History of heart transplantation or other solid-organ transplantation
• Severe heart failure, defined as New York Heart Association (NYHA) functional class IV or left ventricular ejection fraction (LVEF) ≤20%
• History of severe congenital heart disease, valvular heart disease, myocardial disease, pericardial disease, or aortic dissection
• Pregnancy, breastfeeding, or plans to become pregnant during the study period
• Progressive life-threatening disease
• History of alcohol or drug abuse
• Current treatment for a psychiatric disorder
• Current receipt of radiotherapy or chemotherapy for a malignant tumor
• Acute or chronic infectious disease
• Severe hepatic insufficiency, renal insufficiency, thyroid disease and autoimmune disease
• Life expectancy of less than 5 years
• Ophthalmic diseases affecting the retinal vasculature or optic disc structure, including retinal artery occlusion, retinal vein occlusion, glaucoma, or congenital optic disc abnormalities
• Color fundus photographs of insufficient quality because of severe ocular media opacity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CAD group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gensini Score	The Gensini score is used to assess the angiographic severity of coronary artery disease. The minimum score is 0, with no predefined maximum score. Higher scores indicate more severe coronary artery disease and a worse outcome.The Gensini score will be calculated only for patients who undergo coronary angiography and have no history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).	Within 7 days of coronary angiography during hospitalization
SYNTAX Score	The Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score is used to assess the anatomical complexity of coronary artery disease.The minimum score is 0, with no predefined maximum score. Higher scores indicate more severe coronary artery disease and a worse outcome.The SYNTAX score will be calculated only for patients who undergo coronary angiography and have no history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).	Within 7 days of coronary angiography during hospitalization
Number of participants with coronary artery disease		Within 7 days of coronary angiography during hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Cardiovascular Events	At 6 months and 1 year after hospital discharge

Collaborators and Investigators

• Sponsor: Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 16, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2024-1-4051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No