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临床试验/NCT05138731
NCT05138731Unknown不适用

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

General Hospital of Ningxia Medical University5 个研究点 分布在 1 个国家目标入组 821 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
821
试验地点
5
主要终点
Death

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%

排除标准

  • 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
  • Human immunodeficiency virus / acquired immunodeficiency syndrome
  • Hepatitis B and hepatitis C

结局指标

主要结局

Death

时间窗: Follow-up is expected to end on December 30, 2022

A composite of death from cardiovascular causes in patients with CAD

次要结局

  • Major adverse cardiovascular events(Follow-up is expected to end on December 30, 2022)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun He

vice director of the department of cardiovascular internal medicine

General Hospital of Ningxia Medical University

研究点 (5)

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