Identification and Functional Study of Novel Biomarkers for Cardiovascular Diseases

NCT06690684 · tracked via the Priya Life Science China tracker

Sponsor

Ya-Wei Xu

Phase

Observational

Started

2023-10-17

Last updated

2024-11-15

Condition(s) studied

AngiocardiographyHeart FailureIschemic Heart DiseaseAcute Myocardial Infarction (AMI)

Investigational drug(s) / intervention(s)

Hematological indicatorsSerological indicators in patients with myocardial infarctionLevels of biomarkers in blood of patients with acute myocardial infarction

Hematological indicators: This project is a retrospective clinical cohort study. STEMI patients undergoing PCI were selected to explore whether hematological indicators such as PIV, SHR, and Lp(a) can improve the accuracy of predicting short-term MACE events in STEMI patients.

Serological indicators in patients with myocardial infarction: This study selected STEMI patients who underwent PCI and collected their hematological indicators to explore the value of PIV, SHR, Lp(a) and other indicators in improving the accuracy of predicting MACE in STEMI patients in the short term.

Levels of biomarkers in blood of patients with acute myocardial infarction: Hemoglobin, neutrophil count, lymphocyte count, monocyte count and platelet count values, N-terminal pro-B type natriuretic peptide (NT-proBNP), peak creatine kinase isoenzymes (CK-MB), peak troponin T levels, total cholesterol (TC), fasting blood glucose (FBG), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and blood urine nitrogen, blood creatinine (Cr) and other indicators

Study summary

Cardiovascular diseases, mainly represented by ischemic heart disease and heart failure, are the number one killers of human health today. The China Cardiovascular Health and Disease Report 2022 pointed out that the current number of people suffering from cardiovascular diseases in China is 330 million, and cardiovascular diseases account for the highest proportion of disease deaths among urban and rural residents. With the increase of the population and the progress of aging in recent years, the number of patients with cardiovascular diseases is still increasing. Level three prevention is an important part of the long-term management of patients with cardiovascular diseases. Early identification of high-risk groups among patients with cardiovascular diseases and individualized and accurate treatment can greatly reduce the probability of cardiovascular events in patients, improve the quality of life and prognosis of patients, and reduce overall medical economic expenditure. However, at present, there is still a lack of effective biological markers in clinical practice that can give patients accurate positioning in all aspects. In this project, we intend to carry out the following research: (1) Based on real-world cohort research and observation, through proteomics, genomics, transcriptomics, metabolomics, etc., we will explore biomarkers that can be used for the evaluation of cardiovascular diseases from peripheral serum samples of patients with cardiovascular disease (2) Based on true The cohort research observation in the real world clarifies the effectiveness of the biomarkers screened in the first part of the research content and the correlation with the prognosis of the disease (3) Through bioinformatics analysis and basic function research, the function of the selected biomarkers and the mechanism of action in the organism are clarified. This project is expected to provide new criteria and theoretical basis for the prognostic management of clinical cardiovascular diseases.

Eligibility

Sex

ALL

Min age

30 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1\. Subjects must be 30 years old and older at the time of signing the informed consent form. Subject type and disease characteristics: 1. Patients diagnosed with myocardial infarction, Killip I-V, mainly due to myocardial infarction, emergency department or hospitalization 2. (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). Exclusion Criteria: 1. eGFR \< 25 mL/min/1.73 m2 at the screening visit; 2. Serum/plasma potassium \> 5.0 mmol/L at the screening visit; 3. Acute inflammatory heart disease within 60 days before enrollment; 4. Coronary artery bypass grafting within 90 days before enrollment; 5. Stroke or transient ischemic attack within 30 days before enrollment; 6. The researcher believes that the subject's symptoms may be caused by other reasons, such as the patient's dyspnea symptoms may be caused by severe lung disease, anemia or obesity. Specifically, patients with only symptoms and no organic cardiac changes were excluded due to the following circumstances: 7. Systolic blood pressure (SBP) ≥160 mmHg and not receiving ≥3 antihypertensive drugs or ≥180 mmHg (regardless of the treatment received) for 2 consecutive measurements at least 2 minutes apart at screening; 8\. Life-threatening or uncontrollable arrhythmias at screening, including but not limited to: sustained ventricular tachycardia, or atrial flutter with a resting ventricular rate \>110 bpm; 9. Symptomatic hypotension (average systolic blood pressure \<90 mmHg ) during the screening period; 10. Left ventricular assist device installed at screening; 11. History of hyperkalemia or acute renal failure for more than 7 consecutive days during MRA treatment; 12. Pregnant or lactating (lactating) women, where pregnancy is defined as the state of a woman from conception until termination of pregnancy, and confirmed by a positive human chorionic gonadotropin urine or serum test result; 13. Liver dysfunction classified as Hild-Pugh grade C at screening.

Primary outcome measure(s)

MACE — From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 5 years.
The composite events include a composite of all-cause mortality (death due to any cause), cardiovascular mortality (death due to cardiac cause), and heart failure rehospitalization.

Trial sites (1)

Facility	City	Region	Status
Jing 'an District, Shanghai City	Shanghai	Jing 'an District

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06690684 on ClinicalTrials.gov ↗ ← All trials in China