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临床试验/NCT04033861
NCT04033861招募中4 期

Prospective Observational Clinical Study:The Impact of Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2019年6月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
352
试验地点
1
主要终点
Compound endpoints of epicardium and endocardium perfusion

研究概览

简要总结

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

详细描述

As prospectively observational study,it brings anterior acute myocardial infarct patients from 2018 JAN. to 2019 JAN, whose predefined time between symptom onset and percutaneous is not more than 12 hours. The door-to-balloon time, present to balloon time and first medical contact-to-balloon time will be documented. ECG in FMC and 90min after PCI also will be record. Patients assigned to the rhBNP group will receive intravenous rhBNP before PCI,and the variety of heart rate and blood pressure will be record. Routinely evaluation of corrected TIMI frame counting(CTFC), TIMI myocardial perfusion frame counting and TIMI myocardial perfusion grade(TMPG).Blood tests including BNP, CK-MB and CRP are measured at admission and6, 12, 24, 48 hours after PCI. Both Cardiovascular magnetic imaging and echocardiography will be applied in Day 30 and 12 months. The composite endpoint is incidence of all-cause mortality, reinfarct, stroke and target vessel revascularization at hospitalization and follow-up. Principally patients are prevented from any drug affecting microcirculation (GPIIb/IIa receptor agonist, vascular dilation drug, etc.), otherwise it is necessary, which should be documented.

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
Double (Participant, Investigator)

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

  • 未提供

排除标准

  • 未提供

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

Compound endpoints of epicardium and endocardium perfusion

时间窗: 90min after infarct related artery revascularization

Both the TIMI and TMPG score reach 3 immediately after PCI, besides ST resolution≥70% at 90min after PCI.

次要结局

  • Wall motion score index (WMSI) and LVEF by echocardiography(Day 1, 3, 7, 30 and 12 month after PCI)
  • ST-segment Resolution(90 mins after PCI)
  • TIMI Flow Grade (TFG)(One mins after PCI)
  • TIMI Frame Count (CTFC)(One mins after PCI)
  • TIMI Myocardial Perfusion Grade (TMPG)(One mins after PCI)
  • TIMI Myocardial Perfusion Frame Count (TMPFC)(One mins after PCI)
  • CMR imaging(Day 1, 3, 7, 30 and 12 month after PCI)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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