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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of participants with coronary artery disease

Time frame: Within 7 days of coronary angiography during hospitalization
Gensini Score

Time frame: Within 7 days of coronary angiography during hospitalization

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).
SYNTAX Score

Time frame: Within 7 days of coronary angiography during hospitalization

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).

Secondary outcomes

Major Adverse Cardiovascular Events

Time frame: At 6 months and 1 year after hospital discharge

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Aug 19, 2026
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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