Clinical trial NCT05138731: Metabolomics Profiling of Coronary Heart Disease
Official title: LC-MS Based Metabolomics Study of Coronary Heart Disease: Diagnostic and Prognostic Value of Metabolites
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomarkers
Keywords: metabolomics
biomarkers
liquid chromatography-mass spectrometry
coronary artery disease
serum
urine
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 821 subjects will be recruited from 5 centers in different hospitals.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: Follow-up is expected to end on December 30, 2022
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: Follow-up is expected to end on December 30, 2022
Other outcomes:
Locations:
city: Guyuan
country: China
facility: Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region
state: Ningxia
city: Shizuishan
country: China
facility: Fifth People's Hospital of Ningxia Autonomous Region
state: Ningxia
city: Yinchuan
country: China
facility: Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Yinchuan
country: China
facility: Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Hechun Xia, MA
role: STUDY_CHAIR
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