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NCT Number: NCT07655479

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

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

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Key information

Conditions

Cardiogenic Shock Post Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escalation to more capable microaxial flow-pump (Impella 5.5)

Device

Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

Primary outcomes

  1. Vasoactive Hemodynamic Score (VHS) < 5

    Time frame: 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)

Secondary outcomes

  1. All-cause mortality

    Time frame: In-hospital or 30 days post revascularization (whatever comes first)

  2. All-cause mortality

    Time frame: 180 days post revascularization

  3. Cardiac output

    Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.

    measured by pulmonary artery catheter (PAC) [l/min]

  4. Vasoactive-Inotropic Score (VIS)

    Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.

    Vasoactive-Inotropic Score (VIS): A composite measure of vasoactive and inotropic medication support. Scores range from 0 to no fixed maximum, with higher scores indicating greater vasoactive/inotropic support requirements and therefore a worse clinical status and prognosis.

    VIS=dopamine + dobutamine + 100×epinephrine + 10×milrinone + 10,000×vasopressin + 100×norepinephrine

    (all doses in μg/kg/min except vasopressin in U/kg/min)

  5. Lactate

    Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularisation

    Arterial lactate measured by blood gas analysis [mmol/l]

  6. Perfusion

    Time frame: At time of enrolment and 48 hours post revascularization.

    Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]

  7. 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.

    Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)

  8. 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.

    Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair

  9. Haemolysis

    Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.

    Prevalence of clinically relevant haemolysis according to SHARC definitions

  10. 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.

    Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging

  11. 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.

    Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)

  12. 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.

  13. Access site infection

    Time frame: During the index hospitalization, specifically from timepoint of initial revascularisation until discharge from the index hospitalization or death (whichever comes first), at the timepoint of surgical intervention up to 30 days.

    Access site infection with the need to surgical intervention

  14. Time to extubation

    Time frame: At 30 days post revascularization

    Time to extubation in hours

  15. Time to ambulation

    Time frame: At 30 days post revascularization

    Time to ambulation in hours

  16. Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant

    Time frame: At 30 days and 180 days post revascularization

    Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant

  17. Major adverse kidney events (MAKE)

    Time frame: At 30 days and 180 days post revascularization

    Death (from any cause) or new requirement for renal replacement therapy (RRT) (e.g., dialysis) or persistent renal dysfunction (PRD) (defined as a worsening of kidney function denoted by ≥ 25% decline in the estimated glomerular filtration rate (eGFR) from baseline)

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Heyne, Dr. med.

CONTACT

[email protected]

+4915125364083

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Rapid Impella Support and Escalation Trial

Acronym: RISE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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