Metabolomics Profiling of Coronary Heart Disease

General Hospital of Ningxia Medical University

Status: Unknown

Conditions: Biomarkers

Treatments: Other: treatments according guidelines

Study type: Observational

Funder types: Other

Identifiers

NCT05138731

JH

Details and patient eligibility

About

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

Full 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.

Enrollment: 821 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

821 participants in 7 patient groups

Stable angina (SA)

Description:

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.

Treatment:

Other: treatments according guidelines

Unstable angina (UA）

Description:

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.

Treatment:

Other: treatments according guidelines

Acute non-ST-segment elevation myocardial infarction （NSTEMI）

Description:

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.

Treatment:

Other: treatments according guidelines

Acute ST-segment elevation myocardial infarction （STEMI）

Description:

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.

Treatment:

Other: treatments according guidelines

normal coronary artery （NCA）

Description:

symptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain)

Treatment:

Other: treatments according guidelines

nonobstructive coronary atherosclerosis （NOCA）

Description:

stenosis \< 50% in coronary arteries

Treatment:

Other: treatments according guidelines

healthy volunteers

Description:

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