Metabolomics Profiling of Coronary Heart Disease

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05138731

Collaborator

(none)

821

Enrollment

Locations

31.9

Anticipated Duration (Months)

164.2

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Biomarkers	Other: treatments according guidelines

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 Design

Study Type:

Observational

Anticipated Enrollment :

821 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region	Guyuan	Ningxia	China	756000
2	Fifth People's Hospital of Ningxia Autonomous Region	Shizuishan	Ningxia	China	753000
3	Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750000
4	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia	China	750000
5	Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004