Clinical trial NCT06463808: Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
Official title: Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Remodeling
Myocardial Infarction, Anterior Wall
Keywords: Myocardial Infarction, Anterior Wall
Recombinant Human Brain Natriuretic Peptide
Ventricular Remodeling
Percutaneous Coronary Intervention
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who are about 18 to 75 years old get the first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ) and undergo emergency PCI within the effective time window,after which the blood reflows ( TIMI = 3 ).

Brief summary: This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).


Eligibility criteria: Inclusion Criteria:

1. The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
2. Age 18-75 years old, gender unlimited
3. Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
4. Successful reflow after interventional therapy ( TIMI = 3 ).
5. To understand and sign the informed consent.

Exclusion Criteria：

1. Patients with a history of coronary artery bypass grafting
2. Patients with cardiogenic shock
3. Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
4. Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
5. Patients with suspected aortic dissection
6. Patients with severe liver and kidney dysfunction
7. Allergic or intolerant to rhBNP.
8. Patients with chronic renal insufficiency requiring long-term dialysis
9. Patients using diuretics during the screening period
10. Pregnant / lactating women
11. Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc

Primary outcomes:
measure: ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
timeFrame: from baseline to 6 months
measure: ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
timeFrame: from baseline to 6 months
measure: ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
timeFrame: from baseline to 6 months
measure: N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
timeFrame: from baseline to 6 months
measure: The level of Cardiac Troponin T(cTnT)
timeFrame: from baseline to 6 months
Secondary outcomes:
measure: Adverse cardiovascular events
timeFrame: from baseline to 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: