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

Official title

Rapid Impella Support and Escalation Trial

Overview

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

Detailed description

By examining best-practice MCS management and the role of early escalation to Impella 5.5™ in clinical routine care for high-risk patients with deteriorating shock, the study seeks to investigate current treatment strategies that ensure the most appropriate device selection and support intensity at the earliest clinically meaningful time point. This observational approach aims to advance the optimal management of ACS-CS while addressing the complications reported in the DanGer Shock trial.

Interventions

• Device Escalation to more capable microaxial flow-pump (Impella 5.5)
  Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

Primary outcome measures

• Vasoactive Hemodynamic Score (VHS) < 5 [Time frame: 48 hours post revascularization]

Secondary outcome measures (12)

• All-cause mortality [Time frame: In-hospital or 30 days post revascularization (whatever comes first)]
• All-cause mortality [Time frame: 180 days post revascularization]
• Cardiac output [Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.]
• Vasoactive-Inotropic Score (VIS) [Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.]
• Lactate [Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularisation]
• Perfusion [Time frame: At time of enrolment and 48 hours post revascularization.]
• Major Bleeding [Time frame: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) until the first documented bleeding event.]
• Ischemia of the extremities [Time frame: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timepoint of intervention/surgery assessed up to 30 days.]
• Haemolysis [Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.]
• Cerebral events [Time frame: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) assessed up to 30 days.]
• Acute kidney injury (AKI) [Time frame: Every event during the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first), assessed at the timepoint of occurence up to 30 days.]
• Sepsis with positive blood culture [Time frame: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death of any cause (whichever comes first) at the timpoint of first positive blood culture up to 30 days.]

Eligibility criteria

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:

• 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 1 center

• University Hospital Cologne — Cologne

Identifiers

NCT: NCT07655479 · 25-1387 · HORIZON-JU-IHI-2025-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗