Stepping up heart pump support in cardiogenic shock after a heart attack
Looks at moving to a stronger Impella 5.5 heart pump after a heart attack.
Plain-language title generated from the registry record
Registry title: Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support
Key facts
- Where
- Cologne, Düsseldorf, and Kiel, GermanySee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 77 years old?
Source: NCT07655479, who can take part
Where in Germany
- University Hospital CologneCologne, GermanyTaking people
- University Hospital DüsseldorfDüsseldorf, GermanyTaking people
- University Hospital Schleswig-Holstein, Campus KIELKiel, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of Cologne
- Trial code
- NCT07655479
- Record updated
- 27 August 2026
- Original description
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 infarctionRead full original descriptionShow less
Rapid Impella Support and Escalation Trial
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
Inclusion: 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.
Exclusion: 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; Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation; Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO; Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions; 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); Any contraindication listed in the Impella 5.5 IFU if known to be present; Pregnancy or lactation, if known.