Identification for High Risk of Coronary Heart Disease Based on Quantitative Analysis of Fundus Vessels and Metabolic Molecules
18. august 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
3000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Beijing Hospital
-
Kontakt:
- Xue Yu, Chief Physician
- Telefonnummer: 010-85136132
- E-mail: yuxuemd@aliyun.com
-
Beijing, Beijing Municipality, Kina, 100032
- Ikke rekrutterer endnu
- Beijing Friendship hospital, Capital Medical University
-
Kontakt:
- Hui Chen, Chief Physician
- Telefonnummer: 010-63016616
- E-mail: yuxuemd@aliyun.com
-
Beijing, Beijing Municipality, Kina, 100086
- Afsluttet
- Beijing Haidian Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
CAD group
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gensini Score
Tidsramme: 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).
|
Within 7 days of coronary angiography during hospitalization
|
|
SYNTAX Score
Tidsramme: 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).
|
Within 7 days of coronary angiography during hospitalization
|
|
Number of participants with coronary artery disease
Tidsramme: Within 7 days of coronary angiography during hospitalization
|
Within 7 days of coronary angiography during hospitalization
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Major Adverse Cardiovascular Events
Tidsramme: At 6 months and 1 year after hospital discharge
|
At 6 months and 1 year after hospital discharge
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. maj 2024
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
12. august 2026
Først indsendt, der opfyldte QC-kriterier
16. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-1-4051
Plan for individuelle deltagerdata (IPD)
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