Identification for High Risk of Coronary Heart Disease Based on Quantitative Analysis of Fundus Vessels and Metabolic Molecules
18 augustus 2026 bijgewerkt door: Xue Yu, Beijing Hospital
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.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
3000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Werving
- Beijing Hospital
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Contact:
- Xue Yu, Chief Physician
- Telefoonnummer: 010-85136132
- E-mail: yuxuemd@aliyun.com
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Beijing, Beijing Municipality, China, 100032
- Nog niet aan het werven
- Beijing Friendship hospital, Capital Medical University
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Contact:
- Hui Chen, Chief Physician
- Telefoonnummer: 010-63016616
- E-mail: yuxuemd@aliyun.com
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Beijing, Beijing Municipality, China, 100086
- Voltooid
- Beijing Haidian Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
NVT
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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CAD group
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Gensini Score
Tijdsspanne: Within 7 days of coronary angiography during hospitalization
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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).
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Within 7 days of coronary angiography during hospitalization
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SYNTAX Score
Tijdsspanne: 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).
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Within 7 days of coronary angiography during hospitalization
|
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Number of participants with coronary artery disease
Tijdsspanne: Within 7 days of coronary angiography during hospitalization
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Within 7 days of coronary angiography during hospitalization
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Major Adverse Cardiovascular Events
Tijdsspanne: At 6 months and 1 year after hospital discharge
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At 6 months and 1 year after hospital discharge
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 mei 2024
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
31 december 2027
Studieregistratiedata
Eerst ingediend
12 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
16 augustus 2026
Eerst geplaatst (Werkelijk)
19 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
18 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024-1-4051
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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