Overview
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.
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.
Eligibility
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
