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NCT Number: NCT07773064

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

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

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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

  • Age over 18 years old, informed consent to this study, suspected myocardial ischemia symptoms or multiple cardiovascular disease risk factors, completion of coronary angiography, blood sample collection, completion of binocular fundus color photography during hospitalization, and clinical data are available.

Exclusion criteria

  • 1: Heart transplantation or other organ transplantation

2: Severe cardiac insufficiency (New York Heart Association Grade IV or LVEF≤ 20%)

3: History of severe congenital heart disease, valvular heart disease, myocardial disease, pericardial disease, aortic dissection

4: Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period

5: progressive fatal diseases

6: A history of alcohol or drug abuse

7: Being treated for a mental illness

8: Patients with tumor radiotherapy and chemotherapy

9: Patients with acute and chronic infectious diseases

10: Severe liver and renal insufficiency, thyroid disease, autoimmune disease

11: Expected survival less than 5 years

12: Ophthalmic diseases affecting fundus blood vessels and optic disc structure, such as retinal artery or vein obstruction, glaucoma, congenital optic disc abnormalities, etc. 14) The image quality of fundus color imaging with severe dioptric interstitial opacity.

Treatment and study plan

Primary outcomes

  1. coronary artery disease

    Time frame: Within 7 days of coronary angiography during hospitalization

  2. 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).

  3. 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

  1. 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 19, 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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