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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 77 in cardiogenic shock after a heart attack, who are on an Impella CP heart pump and may be moved up to an Impella 5.5 pump.
- Age
- 18 to 77 years
- Sex
- All sexes can join.
- Disease stage
- Cardiogenic shock after a heart attack (STEMI or NSTEMI) with the blocked artery reopened. Low blood pressure or need for inotropes, lactate above 2.5 mM, and heart pumping strength (EF) below 45%.
- Earlier treatment
- Must have had an Impella CP pump during the first procedure to reopen the artery. Still needs inotropes and/or vasopressors (VIS above 5 and up to 50) 6 hours after that procedure, with the pump at level P7 or above.
- Biomarker or test result
- Lactate above 2.5 mM; left ventricular ejection fraction (EF) below 45%.
Main reasons for not taking part
- VA-ECMO support started within 6 ± 1 hours after the first procedure
- High risk of brain injury from lack of oxygen (MIRACLE2 score above 3)
- Platelet count below 75,000 cells/mm3, bleeding problems, active bleeding, or refusing blood transfusions
- Long-term dialysis or chronic kidney disease stage G5
- Pregnancy or breastfeeding, if known
Read by machine on 12 November 2026.
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, GermanyContact: Sebastian Heyne, Dr. med.Taking people
- University Hospital DüsseldorfDüsseldorf, GermanyContact: Malte Kelm, Prof.Taking people
- University Hospital Schleswig-Holstein, Campus KIELKiel, GermanyContact: Bernd Panholzer, Dr.med.Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.