Metabolomics Profiling of Coronary Heart Disease
- Conditions
- Biomarkers
- Interventions
- Other: treatments according guidelines
- Registration Number
- NCT05138731
- Lead Sponsor
- General Hospital of Ningxia Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 821
- 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%
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stable angina (SA) treatments according guidelines 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. Unstable angina (UA） treatments according guidelines 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. Acute non-ST-segment elevation myocardial infarction （NSTEMI） treatments according guidelines 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. Acute ST-segment elevation myocardial infarction （STEMI） treatments according guidelines 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. normal coronary artery （NCA） treatments according guidelines symptoms of chest pain and no stenosis in coronary arteries (such as myocardial bridging, reflux esophagitis, intercostals neuralgia, cervical spondylopathy, and unexplained chest pain) nonobstructive coronary atherosclerosis （NOCA） treatments according guidelines stenosis \< 50% in coronary arteries
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (5)
Fifth People's Hospital of Ningxia Autonomous Region
🇨🇳Shizuishan, Ningxia, China
Department of Cardiovascular Internal Disease, Guyuan People's Hospital of Ningxia Autonomous Region
🇨🇳Guyuan, Ningxia, China
Affiliated Cardio-Cerebrovascular Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Department of Cardiaovascular Internal Disease, General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China