NCT06690684Enrolling by invitation
Identification and Functional Study of Novel Biomarkers for Cardiovascular Diseases
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- 17 Oct 2023
- Primary completion date
- 30 Oct 2028
- Lead sponsor
- Ya-Wei Xu
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT06690684
What you commit to
- Study type: Observational
- Planned participants: 300
- From 17 Oct 2023 to the primary completion date, 30 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Lab values
- eGFR \< 25 mL/min/1.73 m2 at the screening visit;
- Serum/plasma potassium \> 5.0 mmol/L at the screening visit;
- 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.
Who the study is looking for
- 1\. 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).
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jing 'an District, Shanghai City Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.