Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Patients presenting with large myocardial infarction and signs of persistent ischemia after successful percutaneous coronary intervention, have a poor prognosis with respect to outcome and development of heart failure in the future.
The hypothesis of this study is that in patients in whom persistent ischemia is present, use of intra-aortic balloon pump will be beneficial and improve outcome.
详细描述
In some patients presenting with large myocardial infarction and poor hemodynamic condition, intra-aortic balloon counterpulsation is effective in alleviating cardiogenic shock. In others, the use of intra-aortic balloon pump has no effect at all. The investigators believe this is dependent on the presence of persisting ischemia after successful epicardial reperfusion, known as no-reflow.
In the presence of persisting ischemia, the investigators believe us of the intra-aortic balloon pump will relieve ischemia and improve outcome.
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
- None
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
- •Acute ST-segment elevation myocardial infarction with summed ST-segment deviation ≥15 mm.
- •Insufficient ST-segment resolution (<50%) on the ECG made 10-30 minutes after the primary PCI in the catheterization laboratory.
排除标准
- •Initial summed ST-segment deviation less than 15 mm
- •ST-segment resolution > 50% on the ECG performed in the catheterization laboratory
- •Chest pain onset less than 2 or more than 8 hours before arrival
- •Severe aortic valve stenosis/regurgitation
- •Aortic abnormalities prohibitive for use of intra aortic balloon pump
- •Full blown cardiogenic shock with immediate requirement of left ventricular assist device as judged necessary by the operator
- •Inability to provide informed consent
- •Pregnancy
- •Inability to perform coronary angiography by the femoral approach
研究组 & 干预措施
IABP group
After primary percutaneous coronary intervention, IABP will be implanted for 12-24 hours to alleviate persisting ischemia
干预措施: Intra-aortic balloon pump (Device)
Control group
After primary percutaneous coronary intervention, this group undergoes standard treatment according to the guidelines
结局指标
主要结局
All-cause mortality
时间窗: 30 days and 6 months
Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure
时间窗: 6 months
次要结局
未报告次要终点
研究者
Lokien van Nunen
MD
Catharina Ziekenhuis Eindhoven