Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
- •Age 18-75 years old, gender unlimited
- •Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
- •Successful reflow after interventional therapy ( TIMI = 3 ).
- •To understand and sign the informed consent.
- •Exclusion Criteria：
- •Patients with a history of coronary artery bypass grafting
- •Patients with cardiogenic shock
- •Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
- •Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
- •Patients with suspected aortic dissection
- •Patients with severe liver and kidney dysfunction
- •Allergic or intolerant to rhBNP.
- •Patients with chronic renal insufficiency requiring long-term dialysis
- •Patients using diuretics during the screening period
- •Pregnant / lactating women
- •Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc
排除标准
- 未提供
研究组 & 干预措施
patients who take Recombinant Human Brain Natriuretic Peptide
干预措施: Recombinant Human Brain Natriuretic Peptide (Drug)
结局指标
主要结局
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
时间窗: from baseline to 6 months
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
时间窗: from baseline to 6 months
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
时间窗: 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
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
时间窗: from baseline to 6 months
LVEF refers to the percentage of stroke output to left ventricular end-diastolic
The level of Cardiac Troponin T(cTnT)
时间窗: from baseline to 6 months
The level of Cardiac Troponin T(cTnT) at 6 month
次要结局
- Adverse cardiovascular events(from baseline to 6 months)