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NCT07655479
Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support
Conditions: Cardiogenic Shock Post Myocardial Infarction
Sex: All
Ages: 18 Years – 77 Years
Healthy volunteers: No
Enrollment: 115
Sponsor: University Hospital of Cologne
Location: University Hospital Düsseldorf Düsseldorf North Rhine-Westphalia
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 \
Source: ClinicalTrials.gov (NCT07655479). StuddyBuddy aggregates publicly available trial information.