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

Rapid Impella Support and Escalation Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiogenic Shock Post Myocardial Infarction
• Intervention / Treatment: Device: Escalation to more capable microaxial flow-pump (Impella 5.5)

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.

• Study Type: Observational
• Enrollment (Estimated): 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Device Group; Rapid escalation to Impella 5.5	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasoactive Hemodynamic Score (VHS) < 5	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)	48 hours post revascularization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		In-hospital or 30 days post revascularization (whatever comes first)
All-cause mortality		180 days post revascularization
Cardiac output	measured by pulmonary artery catheter (PAC) [l/min]	At time of enrolment, 48 hours as well as 72 hours post revascularization.
Vasoactive-Inotropic Score (VIS)	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)	At time of enrolment, 48 hours as well as 72 hours post revascularization.
Lactate	Arterial lactate measured by blood gas analysis [mmol/l]	At time of enrolment, 48 hours as well as 72 hours post revascularisation
Perfusion	Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]	At time of enrolment and 48 hours post revascularization.
Major Bleeding	Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)	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	Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair	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	Prevalence of clinically relevant haemolysis according to SHARC definitions	At time of enrolment, 48 hours as well as 72 hours post revascularization.
Cerebral events	Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging	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)	Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)	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		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.
Access site infection	Access site infection with the need to surgical intervention	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.
Time to extubation	Time to extubation in hours	At 30 days post revascularization
Time to ambulation	Time to ambulation in hours	At 30 days post revascularization
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant	Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant	At 30 days and 180 days post revascularization
Major adverse kidney events (MAKE)	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)	At 30 days and 180 days post revascularization

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: myocardial infarction; cardiogenic shock; Impella; Microaxial Flow-pump
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic; Myocardial Infarction
• Other Study ID Numbers: 25-1387; HORIZON-JU-IHI-2025-09 (Other Grant/Funding Number: IHI Joint Undertaking)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to data protection regulations and study contracts

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes