Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associat… (NCT07655479) | Clinical Trial Compass
RecruitingNot Applicable
Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support
Germany115 participantsStarted 2026-04-23
Plain-language summary
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
Who can participate
Age range
18 Years – 77 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a microaxial flow pump — a mechanical device inserted into the heart — for cardiogenic shock after a heart attack; given how serious my situation is, can you walk me through exactly how this device would be used and what risks come with it compared to the medications I'm already on?
2The trial is measuring something called a Vasoactive Hemodynamic Score below 5 as its main goal — can you explain what that score means for my heart's stability and whether reducing my need for vasopressors or inotropes is a realistic target in my case?
3Since this trial is listed as 'not yet recruiting,' it may not be open when I need help most urgently — what treatment options are available to me right now if I can't wait for this study to start?
4This trial appears to focus on patients who still need hemodynamic support after initial treatment for cardiogenic shock — does my current condition match that kind of persistent, ongoing need, or am I at a different stage where this approach might not apply?
5Because this trial is in a non-standard phase category and the device involves mechanical heart support, how much is already known about the safety of escalating pump support in patients like me, and what would happen if the device didn't improve my hemodynamics as hoped?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
Exclusion criteria
. 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