Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
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
- 否
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
Fabrizio D'Ascenzo
Medical Doctor
University of Turin, Italy
