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

Korábbi kezelés

• 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

Más betegség

• 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

Laborértékek

• Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions

Egyéb

• 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

• 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.