Identification and Functional Study of Novel Biomarkers for Cardiovascular Diseases
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2023
CompletedFirst Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
November 15, 2024
November 1, 2024
5 years
November 14, 2024
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE
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.
From the time of hospital discharge until the event of specific outcome, death, or loss to follow up, maximum 5 years.
Study Arms (1)
PCI in patients with acute myocardial infarction
Interventions
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.
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.
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
Eligibility Criteria
Patients with acute myocardial infarction or heart failure
You may qualify if:
- \. Subjects must be 30 years old and older at the time of signing the informed consent form.
- Subject type and disease characteristics:
- Patients diagnosed with myocardial infarction, Killip I-V, mainly due to myocardial infarction, emergency department or hospitalization
- (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).
You may not qualify if:
- eGFR \< 25 mL/min/1.73 m2 at the screening visit;
- Serum/plasma potassium \> 5.0 mmol/L at the screening visit;
- Acute inflammatory heart disease within 60 days before enrollment;
- Coronary artery bypass grafting within 90 days before enrollment;
- Stroke or transient ischemic attack within 30 days before enrollment;
- 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;
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ya-Wei Xulead
Study Sites (1)
Jing 'an District, Shanghai City
Shanghai, Jing 'an District, 200072, China
Biospecimen
BLOOD
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Shanghai 10th People's Hospital (Responsible Party)
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 15, 2024
Study Start
October 17, 2023
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
November 15, 2024
Record last verified: 2024-11