In this project, we will plan to carry out the following research: (1) Based on real-world cohort study observations, explore biomarkers that can be used for tertiary prevention assessment of cardiovascular disease from peripheral serum samples of cardiovascular disease patients through proteomics, genomics, transcriptomics, metabolomics, etc.(2) Based on real-world cohort study observations, clarify the effectiveness of the biomarkers screened in the first part of the research content and their correlation with disease prognosis (3) Through bioinformatics analysis and basic functional research, Clarify the functions of the screened biomarkers and their mechanisms of action in vivo. This project is expected to provide new evaluation criteria and theoretical basis for clinical cardiovascular disease prognostic management.
The specific research plan is as follows:
1. Study population: Patients diagnosed with myocardial infarction or heart failure (NYHA II-IV)
2. Inclusion criteria: 1. Subjects must be 30 years old or older when signing the informed consent form. Subject type and disease characteristics: a. Patients diagnosed with myocardial infarction, Killip I-V, mainly due to myocardial infarction, emergency department or hospitalization b. (1). Patients diagnosed with heart failure, NYHAII-IV, who came to outpatient clinics or hospitalizations mainly due to heart failure (2). Received diuretics within 30 days before enrollment (3). Structural cardiac abnormalities based on any local imaging measurements within the past 12 months (latest screening), defined as at least one of the following: oLAD≥ 3.8 cm, LAA≥20 cm2, LAVI\>30mL/m2, LVMI≥115g/m2 (MIN)/95g/m2 (MIN), septum thickness or posterior wall thickness ≥ 1.1 cm (4). Subjects in sinus rhythm: NT-proBNP≥300pg/mL (BNP≥100pg/mL) or subjects with atrial fibrillation (or if atrial fibrillation status is unknown): NT-proBNP≥900pg/mL (BNP≥300pg/mL).
3. Exclusion criteria: 1. eGFR\<25mL/min/1.73m2 at the screening visit;2. Serum/plasma potassium\>5.0mmol/L at the screening visit;3. Acute inflammatory heart disease occurred within 60 days before enrollment;4. Coronary artery bypass surgery occurred 90 days before enrollment;6. Stroke or transient ischemic attack occurred within 30 days before enrollment; 7. The investigator believes that the subject's symptoms may be caused by other reasons, such as the patient's symptoms of difficulty breathing may be caused by severe lung disease, anemia or obesity. Specifically, patients with only symptoms and no organic cardiac changes due to the following conditions were excluded;8 2 consecutive measurements taken at least 2 minutes apart at screening, systolic blood pressure (SBP) ≥160mmHg and not receiving ≥3 antihypertensive drugs or ≥180mmHg (regardless of treatment);9. Life-threatening or uncontrollable arrhythmia at screening, including but not limited to: sustained ventricular tachycardia, or atrial flutter with resting ventricular rate\>110bpm;10. Symptomatic hypotension at screening (Mean systolic blood pressure \<90mmHg) 11. Had a left ventricular assist device at screening;12. Had a history of hyperkalemia or acute renal failure for\>7 consecutive days during MRA treatment;13. Pregnant or nursing (lactation) women, where pregnancy is defined as the woman's condition after conception until termination of pregnancy, and a confirmed positive urine or serum test result for human chorionic gonadotropin;14. Have liver dysfunction classified as Child-PughC at screening.
4. Study process: Enrolled patients will be divided into two groups: myocardial infarction group and heart failure group based on the enrolled disease. Patients in the two groups have received standardized reperfusion therapy + ischemic cardiomyopathy treatment and anti-heart failure treatment respectively since the start of the study. Patients will be collected once before the start of treatment. Each patient needs to complete an enrollment assessment at the time of enrollment, and follow-up needs to be completed every year during the treatment period until the endpoint event occurs, or 5-year follow-up is completed.
5. Clinical data collection content:
All patients were required to complete general conditions, laboratory tests and auxiliary tests at enrollment, and major cardiovascular events and readmission events related to cardiovascular diseases were recorded during the follow-up period.
General conditions include: height, weight, age, gender, BMI, blood pressure, heart rate Laboratory tests and auxiliary tests include: NT-proBNP, BNP, blood routine (white blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hb), hematocrit, platelets, mean corpuscular hemoglobin content (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), corpuscular volume distribution width (RDW)), liver and kidney function (Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), creatine kinase (CK), serum creatinine, eGFR, blood urea nitrogen, bilirubin, electrolytes (sodium, serum potassium), thyroid function, urine routine examination, glycosylated hemoglobin, cardiac color Doppler examination Biological sample testing includes: proteomics, genomics, transcriptomics, metabolomics, etc.
Major cardiovascular events: acute myocardial infarction, stroke, cardiovascular death
