Progress Bifurcation Global Registry
NCT05100992
Arterial Occlusive Diseases, Arteriosclerosis
Minneapolis, Minnesota, United States
View Trial DetailsNCT Number: NCT07773064
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 7 days of coronary angiography during hospitalization
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).
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).
Time frame: At 6 months and 1 year after hospital discharge
Beijing Hospital
Other Gov
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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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