Identification and Functional Study of Novel Biomarkers for Cardiovascular Diseases
Launched by YA-WEI XU · Nov 14, 2024
Trial Information
Current as of June 29, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 rese...
Gender
ALL
Eligibility criteria
- 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.
About Ya Wei Xu
Ya-Wei Xu is a distinguished clinical trial sponsor known for advancing innovative therapeutic solutions through rigorous research and development. With a strong focus on enhancing patient outcomes, the organization is dedicated to conducting high-quality clinical trials that adhere to ethical standards and regulatory guidelines. Leveraging a collaborative approach, Ya-Wei Xu engages with a network of healthcare professionals, researchers, and stakeholders to ensure the successful design and execution of trials across various therapeutic areas. Their commitment to scientific excellence and patient-centric methodologies positions them as a leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Jing 'An District, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported