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Metabolomics Profiling of Coronary Heart Disease

LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05138731
Enrollment
821
Registered
2021-12-01
Start date
2020-10-01
Completion date
2023-05-30
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers

Keywords

metabolomics, biomarkers, liquid chromatography-mass spectrometry, coronary artery disease, serum, urine

Brief summary

This study sought to assess the diagnostic and prognostic values of metabolomics in coronary artery disease(CAD).

Detailed description

The purpose of this study is to establish a powerful diagnostic and prognostic model based on metabolites in CAD patients.A total of 821 hospitalized patients with CAD and 200 healthy volunteers are enrolled.Specifically, 200 CAD patients from single-centre are regarded as discovery set, 300 CAD patients from multicentre are regarded as validation set. A third independent set including 321patitents is regarded as application set. Untargeted and targeted metabolomics analysis about serum and urine samples in all subjects will be performed using high-performance liquid chromatography coupled with mass spectrometry technology. Univariate and multivariate analysis methods are used to extract and analyze the differential mebabolites. By exploring the relationship between the differential mebabolites and clinical manifestions, a set of diagnostic biomarkers for CAD will be identified. By elucidating the correlation between the differential mebabolites and MACEs, a effective prognostic model will be established. Adverse events are defined as the combined endpoints of death or major adverse cardiovascular events(MACEs) in patients with CAD for at least 1 year follow-up after discharge. In brief, we aim to establish valuabe diagnostic and predictive models based on novel baseline metabolites in patients with CAD.

Interventions

OTHERtreatments according guidelines

different group intervened with different treatment following guidelines/consensuses accordingly

Sponsors

General Hospital of Ningxia Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

* Objective evidence of coronary heart disease risk factors * Or angina pectoris symptoms * Or ECG ischemic changes * Or elevated myocardial enzymes, myocardial radionuclide scanning showing myocardial filling defect, coronary CT showing coronary stenosis ≥ 50%

Exclusion criteria

* Older than 80 years and younger than 18 years old, * Aortic dissection * Pulmonary embolism * Malignant tumor * Autoimmune diseases * Systemic systemic diseases * Severe infectious diseases * Trauma, surgery in the last three months * Myocarditis, cardiomyopathy, pericarditis, severe congenital heart disease * Syphilis * Human immunodeficiency virus / acquired immunodeficiency syndrome * Hepatitis B and hepatitis C

Design outcomes

Primary

MeasureTime frameDescription
DeathFollow-up is expected to end on December 30, 2022A composite of death from cardiovascular causes in patients with CAD

Secondary

MeasureTime frameDescription
Major adverse cardiovascular eventsFollow-up is expected to end on December 30, 2022Hospitalization for recurrent severe angina pectoris, acute myocardial infarction, revascularization, malignant arrhythmia, new heart failure or acute attack of chronic heart failure, cardiac arrest and stroke.

Countries

China

Contacts

Primary ContactJun He, Ph. D, MD
junhe@nxmu.edu.cn+8613995273232
Backup ContactMeijiao Fu, MA
fumeijiao777@nxmu.edu.cn+8613723376077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026