Metabolomics Profiling of Coronary Heart Disease

December 31, 2021 updated by: Jun He, General Hospital of Ningxia Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Ningxia
      • Guyuan, Ningxia, China, 756000
        • Recruiting
        • Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region
        • Contact:
          • Yanning Zhang, M.A
          • Phone Number: +8613309545199
      • Shizuishan, Ningxia, China, 753000
        • Recruiting
        • Fifth People's Hospital of Ningxia Autonomous Region
        • Contact:
          • Fuqing Ma, M.A
          • Phone Number: +8617709586346
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
          • Shaojing Xi, M.A
          • Phone Number: +8618295107706
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University
        • Contact:
          • Fang Liu, M.A
          • Phone Number: +8618609519633
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University
        • Contact:
        • Principal Investigator:
          • Jun He, Ph.D, MD
        • Sub-Investigator:
          • Meijiao Fu, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

About 821 subjects will be recruited from 5 centers in different hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stable angina (SA)
Typical chronic exersive angina pectoris attacks, lasting several minutes to more than 10 minutes, 3-5 minutes in most cases, generally not more than 30 minutes. The pain disappeared after rest or taking nitrates, and the pain degree, frequency, duration, nature and inducing factors did not change in the last 1-3 months.
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
Unstable angina (UA）
Including resting angina (attack at rest, the duration is usually >20 minutes), primary angina (usually the first symptoms within 1-2 months, very light physical activity can be induced, at least CCSIII level), worsening angina (angina gradually increases on the basis of relatively stable labor angina. More severe pain, longer or more frequent pain, at least grade I increase according to THE CCS classification, at least GRADE II CCSI). TNI was negative, routine electrocardiogram may have transient ST segment depression, T wave low flat or inverted.
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
Acute non-ST-segment elevation myocardial infarction （NSTEMI）
Patients with elevated troponin accompanied by one or more of the following conditions: electrocardiogram showed new ST segment depression or T wave flatness or inversion; Persistent ischemic chest pain; Echocardiography showed abnormal segmental ventricular wall activity. Abnormal coronary angiography.
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
Acute ST-segment elevation myocardial infarction （STEMI）
Troponin was elevated, and ECG showed ST segment arcuate back elevation, accompanied by one or more of the following conditions: persistent ischemic chest pain; Echocardiography showed segmental abnormal ventricular wall activity; Abnormal coronary angiography.
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
normal coronary artery （NCA）
symptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain)
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
nonobstructive coronary atherosclerosis （NOCA）
stenosis < 50% in coronary arteries
Other: treatments according guidelines
different group intervened with different treatment following guidelines/consensuses accordingly
healthy volunteers
Healthy control subjects who had no significant systemic diseases (e.g. ischemic heart disease, hypertension,diabetes,cancer, pulmonary disease, or infectious diseases) were recruited from Physical Examination Center of Ningxia Medical University General Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Follow-up is expected to end on December 30, 2022
A composite of death from cardiovascular causes in patients with CAD
Follow-up is expected to end on December 30, 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 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.
Follow-up is expected to end on December 30, 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Study Chair: Hechun Xia, MA, General Hospital of Ningxia Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

January 30, 2023

Study Completion (ANTICIPATED)

May 30, 2023

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (ACTUAL)

December 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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