LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites
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
- 是
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
Jun He
vice director of the department of cardiovascular internal medicine
General Hospital of Ningxia Medical University
