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

NCT07773064 | Recruiting

• 1 other identifier: 2024-1-4051
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Number of participants with coronary artery disease

  Within 7 days of coronary angiography during hospitalization

• 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

Secondary Outcomes (1)

• Major Adverse Cardiovascular Events

  At 6 months and 1 year after hospital discharge

Study Arms (1)

CAD group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (3)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100032, China

NOT YET RECRUITING

Beijing Haidian Hospital

Beijing, Beijing Municipality, 100086, China

COMPLETED

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Following collection, blood samples will be transported to the laboratory within 1 hour and temporarily stored at 4°C. Trained and qualified laboratory personnel will complete centrifugation within 1 hour of sample receipt. The processed samples will then be aliquoted into tubes containing at least 500 μL per aliquot and immediately stored at -80°C to preserve sample quality and biological integrity. Relevant clinical information and sample conditions, such as lipemia, will also be documented.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start: May 14, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)