NCT07773064 Identification for High Risk of Coronary Heart Disease Based on Quantitative Analysis of Fundus Vessels and Metabolic Molecules
| NCT ID | NCT07773064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Hospital |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-05-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2024-05-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07773064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07773064 currently recruiting?
Yes, NCT07773064 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Hospital to inquire about joining.
Where is the NCT07773064 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT07773064 clinical trial?
NCT07773064 is sponsored by Beijing Hospital. The trial plans to enroll 3,000 participants.