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临床试验/NCT04157868
NCT04157868Unknown4 期

The Impact of Early rhBNP on Myocardial Work in Patients With Anterior ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention

RenJi Hospital0 个研究点目标入组 200 人开始时间: 2019年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
200
主要终点
Global myocardial work efficiency by echocardiography

研究概览

简要总结

The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
  • No contraindication for rhBNP;
  • Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.

排除标准

  • 1.Cardiogenic shock (systolic BP <90mmHg after fluid infusion or systolic BP<100mmHg after vasoactive drugs);
  • History of myocardial infarct;
  • 3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;
  • Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;
  • Pregnant or lactating;
  • life expectancy≤12 months;
  • Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;

研究组 & 干预措施

rhBNP

Experimental

rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.

干预措施: rhBNP (Drug)

Control

Placebo Comparator

Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization.

干预措施: Control (Drug)

结局指标

主要结局

Global myocardial work efficiency by echocardiography

时间窗: 30 days after PCI

Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram. Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.

次要结局

  • Clinical Outcomes(30 days after PCI)
  • Global myocardial constructive work by echocardiography(Day 1, 7, 30 after PCI)
  • Global myocardial waste work by echocardiography(Day 1, 7, 30 after PCI)
  • Global myocardial work index by echocardiography(Day 1, 7, 30 after PCI)

研究者

申办方类型
Other
责任方
Sponsor

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