Metabolomics Profiling of Coronary Heart Disease

• Conditions: Biomarkers

• Registration Number: NCT05138731
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Status Verified: 2021-12
• Study First Posted: 2021-12-01
• Last Update Submitted: 2021-12-31
• Last Update Posted: 2022-01-14
• Primary Completion: 2023-01-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 821

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	Follow-up is expected to end on December 30, 2022	A composite of death from cardiovascular causes in patients with CAD

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	Follow-up is expected to end on December 30, 2022	Hospitalization 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.

Trial Locations

Locations (5)

Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region; 🇨🇳 Guyuan, Ningxia, China

Fifth People's Hospital of Ningxia Autonomous Region; 🇨🇳 Shizuishan, Ningxia, China

Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China

People's Hospital of Ningxia Hui Autonomous Region; 🇨🇳 Yinchuan, Ningxia, China

Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China