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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorBeijing Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 1 trial group
Group A: CAD group

Trial outcomes

Primary outcomes

1

Number of participants with coronary artery disease

Time frame
Within 7 days of coronary angiography during hospitalization
2

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).

Time frame
Within 7 days of coronary angiography during hospitalization
3

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).

Time frame
Within 7 days of coronary angiography during hospitalization

Secondary outcomes

1

Major Adverse Cardiovascular Events

Time frame
At 6 months and 1 year after hospital discharge

Other outcomes

Sponsors and contacts

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