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NCT07773064 · ClinicalTrials.gov record · last posted 2026-08-20

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

StatusRecruiting
PhaseNot specified
Started2024-05-14
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-21
critical
Primary endpoint(s) modified
WasGensini Score, SYNTAX Score, coronary artery disease
NowGensini Score, Number of participants with coronary artery disease, SYNTAX Score
Trial Details
NCT Number NCT07773064
Lead Sponsor Beijing Hospital
Conditions Coronary Artery Disease
Enrollment 3,000 participants
Start Date 2024-05-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20