Rapid escalation from Impella CP to Impella 5.5 in cardiogenic shock after myocardial infarction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study observes patients with acute myocardial infarction–related cardiogenic shock who are supported with an Impella CP and may be escalated to the Impella 5.5. It aims to identify whether a time-optimized escalation strategy leads to better clinical outcomes and fewer adverse events in routine care. The analysis focuses on best-practice microaxial flow-pump management and the timing of escalation within the first 24 hours after revascularisation. The design addresses real-world treatment patterns and complications seen in prior trials such as DanGer Shock. Data collected will be observational and exploratory, without randomization or experimental interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Düsseldorf
  Düsseldorf, North Rhine-Westphalia, Germany Recruiting
• University Hospital Schleswig-Holstein, Campus Kiel
  Kiel, Schleswig-Holstein, Germany Recruiting
• University Hospital Cologne
  Cologne, Germany Recruiting

Study contacts

• Study coordinator: Sebastian Heyne, Dr. med.
• Email: sebastian.heyne@uk-koeln.de
• Phone: +4915125364083

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ivabradine for cardiogenic shock after a heart attack

  A study tests whether taking ivabradine can help people with cardiogenic shock after a heart attack move down at least one class on the SCAI scale and need less time on blood pressure or heart-support medicines.

  Recruiting Phase 3 National Institute of Cardiovascular Diseases, Pakistan · Karachi · NCT07714746

• Optimizing Impella 5.5 Outcomes With Advanced Data Science

  This study tests whether real-world data from Impella 5.5 patients with cardiogenic shock can help predict heart recovery and prevent complications, using advanced data science.

  Recruiting Medical University of Vienna · Vienna · NCT07619144

• Cardiogenic Shock Outcomes Registry (COR-SHOCK): how patients fare over time

  This observational registry tests how outcomes and management of cardiogenic shock have changed over the years in adults receiving routine care.

  Recruiting Hospital de Santa Cruz, Portugal · Carnaxide, Lisbon District · NCT07597291

• Outcomes in patients with mixed cardiogenic and vasoplegic shock

  This registry will try to describe outcomes and risk factors in adults admitted with cardiogenic shock who also have inappropriate vasodilation (mixed cardiogenic‑vasoplegic shock).

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens, Somme · NCT07354568

• Using beta-blockers for heart attack patients in intensive care

  This study is testing if the heart medication metoprolol can help heart attack patients in intensive care feel better and avoid worsening their condition.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT06967194

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.