Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support
Escalation to more capable microaxial flow-pump (Impella 5.5)
Escalation to more capable microaxial flow-pump (Impella 5.5): Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
Study 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
Sex
ALL
Min age
18 Years
Max age
77 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Vasoactive Hemodynamic Score (VHS) < 5 — 48 hours post revascularization Vasoactive Hemodynamic Score = Hemodynamic Score (HS) x Vasoactive-Inotropic Score (VIS)
Higher VHS indicates more severe hemodynamic compromise relative to degree of pharmacological circulatory support. Range: Minimum 1, Maximum 110
Hemodynamic Score:
HS = Points are allocated for measured heart rate, mean arterial blood pressure and arterial lactate (minimum 1, maximum 11)
Vasoactive-Inotropic Score:
Points are allocated for every 10 increment according to the following formula:
Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) + 100 x Epinephrine dose (μg/kg/min) + 10 x Milrinone (μg/kg/min) + 100 x Norepinephrine dose (μg/kg/min) + 50 x Levosimendan dose (μg/kg/min)
Trial sites (3)
Facility
City
Region
Status
University Hospital Düsseldorf
Düsseldorf
North Rhine-Westphalia
Recruiting
University Hospital Schleswig-Holstein, Campus Kiel
Kiel
Schleswig-Holstein
Recruiting
University Hospital Cologne
Cologne
Germany
Recruiting
More University Hospital of Cologne trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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