跳至主要内容
临床试验/NCT06690567
NCT06690567进行中(未招募)不适用

Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention

A.O.U. Città della Salute e della Scienza1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2024年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
700
试验地点
1
主要终点
long-term overall mortality

研究概览

简要总结

The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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 or females ≥ 18 years-old with CS or CHIPs
  • Impella® device implanted (CP, 5, 5.5)

排除标准

  • Age < 18 years
  • No Impella implanted

结局指标

主要结局

long-term overall mortality

时间窗: 12 months

次要结局

  • 30-day overall and cardiovascular mortality(30 day)
  • Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT)(12 months)
  • Rate of bleedings according to the BARC classification(12 months)
  • Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition)(12 months)
  • Rate of neurological events (stroke and TIA)(12 months)

研究者

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabrizio D'Ascenzo

Medical Doctor

University of Turin, Italy

研究点 (1)

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