NCT07655479 Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 115 participants in total. It began in 2026-04-23 with a primary completion date of 2028-10.

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. Age ≥18 years and ≤77 years 2. Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation 3. The following additional parameters must be met at the time of initial revascularisation procedure: 1. Hypotension or need for inotropes AND 2. Lactate \> 2.5 mM AND 3. Left ventricular ejection fraction (EF) \< 45% 4. Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled: 1. Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure 2. Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure 5. 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 6. Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied. Exclusion Criteria: 1. 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. 2. Elevated risk of hypoxic brain injury indicated by MIRACLE2 score \>3 (Aldous et al., 2023) 3. Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions 4. Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation 5. Any contraindication listed in the Impella 5.5 IFU if known to be present 6. Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO 7. Pregnancy or lactation, if known 8. 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

Contact & Investigator

Frequently Asked Questions

Related Trials