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临床试验/NCT02900456
NCT02900456已完成不适用

The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

Rennes University Hospital26 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
177
试验地点
26
主要终点
IABP insertion rate

研究概览

简要总结

Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females at least of 18 of age;
  • Undergoing IABP treatment ;
  • Subject, relatives or legal guardian signified their non-opposition to participate in the study

排除标准

  • - IABP insertion in immediate post-intervention period

结局指标

主要结局

IABP insertion rate

时间窗: 1 year

次要结局

  • Number of cardiogenic shock(1 year)
  • Number of mechanical complication of acute coronary syndrome(1 year)
  • Number of myocardial infarction not shocked(1 year)
  • Number of other indications(1 year)
  • Survival rate following IABP insertion(1 year)
  • IABP-related complications rate and type(1 year)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (26)

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