Rapid heart pump upgrade may save lives in shock
NCT ID NCT07655479
First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This study tests whether quickly upgrading from a standard heart pump (Impella CP) to a more powerful one (Impella 5.5) within 24 hours after a heart attack improves outcomes for people in cardiogenic shock. The trial will enroll 115 adults aged 18-77 who have had a heart attack and need extra heart support. The goal is to see if this faster escalation reduces the need for strong medications and leads to fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Impella heart pumps (Impella CP and Impella 5.5)
- What this could lead to
- If successful, this could lead to a faster, more effective way to support the heart during cardiogenic shock, potentially reducing complications and improving survival.
- What could go wrong
- This is a relatively small, early-stage trial (115 people) and the results may not apply to all patients. The procedure itself carries risks like bleeding or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 115 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with ACS-CS (STEMI or NSTEMI) who undergo Impella CP™-supported revascularisation of the culprit lesion and are considered for escalation to Impella 5.5 at the discretion of the treating investigator will be assessed for eligibility to participate in this observational study.
- Ages
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18 to 77 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Cologne
RECRUITINGCologne, 50937, Germany
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University Hospital Düsseldorf
RECRUITINGDüsseldorf, North Rhine-Westphalia, 40225, Germany
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University Hospital Schleswig-Holstein, Campus Kiel
RECRUITINGKiel, Schleswig-Holstein, 24105, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart rate drug may speed recovery from shock after heart attack
- Can a heart Pump's data predict who will recover?
- 800-Patient registry aims to unlock secrets of heart shock survival
- Could less blood pressure medicine save more lives in heart shock?
- Designer cells aim to calm immune system after massive heart attack
- New study aims to unravel deadly shock combo in heart patients