Rapid Impella Support and Escalation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 3
研究概览
简要总结
The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction
详细描述
By examining best-practice MCS management and the role of early escalation to Impella 5.5™ in clinical routine care for high-risk patients with deteriorating shock, the study seeks to investigate current treatment strategies that ensure the most appropriate device selection and support intensity at the earliest clinically meaningful time point. This observational approach aims to advance the optimal management of ACS-CS while addressing the complications reported in the DanGer Shock trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤77 years
- •Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation
- •The following additional parameters must be met at the time of initial revascularisation procedure:
- •Hypotension or need for inotropes AND
- •Lactate > 2.5 mM AND
- •Left ventricular ejection fraction (EF) < 45%
- •Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
- •Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
- •Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
- •Need for inotropes and/or vasopressors with VIS > 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure
- •Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.
排除标准
- •Implanted VA-ECMOwithin 6 ± 1 hours after initial revascularisation Note: If VA-ECMO support is needed between 6 ± 1 hours after initial revascularisation and escalation to Impella 5.5, patients will be included forlimited data collection per Table 2 only. In this case the same Informed Consent Process as for regular trial participants applies.
- •Elevated risk of hypoxic brain injury indicated by MIRACLE2 score >3 (Aldous et al., 2023)
- •Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions
- •Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation
- •Any contraindication listed in the Impella 5.5 IFU if known to be present
- •Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO
- •Pregnancy or lactation, if known
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint, if known
研究组 & 干预措施
Device Group
Rapid escalation to Impella 5.5
干预措施: Escalation to more capable microaxial flow-pump (Impella 5.5) (Device)
研究者
Stephan Baldus
Prof. Dr. med.
University Hospital of Cologne