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UnknownNCT05138731

Metabolomics Profiling of Coronary Heart Disease

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

Status
Unknown
Phase
Study type
Observational
Enrollment
821 (estimated)
Sponsor
General Hospital of Ningxia Medical University · Academic / Other
Sex
All
Age
18 Years – 79 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERtreatments according guidelinesdifferent group intervened with different treatment following guidelines/consensuses accordingly

Timeline

Start date
2020-10-01
Primary completion
2023-01-30
Completion
2023-05-30
First posted
2021-12-01
Last updated
2022-01-14

Locations

5 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05138731. Inclusion in this directory is not an endorsement.