Myocardial Infarction, Anterior Wall, Ventricular Remodeling
Conditions
Keywords
Myocardial Infarction, Anterior Wall, Recombinant Human Brain Natriuretic Peptide, Ventricular Remodeling, Percutaneous Coronary Intervention
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).
Interventions
we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ultrasonic cardiogram：left ventricle ejection fraction (LVEF) | from baseline to 6 months | LVEF refers to the percentage of stroke output to left ventricular end-diastolic |
| ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI) | from baseline to 6 months | LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area |
| ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI) | from baseline to 6 months | LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area |
| N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level | from baseline to 6 months | NT-proBNP is a protein which is an ingredient for making the BNP hormone and a sign of heart failure can be obteined by blood |
| The level of Cardiac Troponin T(cTnT) | from baseline to 6 months | The level of Cardiac Troponin T(cTnT) at 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Adverse cardiovascular events | from baseline to 6 months |
Countries
China
Contacts
Primary ContactLianSheng Wang
Backup ContactYang Yang
Outcome results
None listed