Identification for High Risk of Coronary Heart Disease Based on Quantitative Analysis of Fundus Vessels and Metabolic Molecules
18 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
3000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Rekrytering
- Beijing Hospital
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Kontakt:
- Xue Yu, Chief Physician
- Telefonnummer: 010-85136132
- E-post: yuxuemd@aliyun.com
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Beijing, Beijing Municipality, Kina, 100032
- Har inte rekryterat ännu
- Beijing Friendship hospital, Capital Medical University
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Kontakt:
- Hui Chen, Chief Physician
- Telefonnummer: 010-63016616
- E-post: yuxuemd@aliyun.com
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Beijing, Beijing Municipality, Kina, 100086
- Avslutad
- Beijing Haidian Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
N/A
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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CAD group
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Gensini Score
Tidsram: 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
Tidsram: 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
Tidsram: Within 7 days of coronary angiography during hospitalization
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Within 7 days of coronary angiography during hospitalization
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Major Adverse Cardiovascular Events
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 maj 2024
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
12 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2026
Första postat (Faktisk)
19 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-1-4051
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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