Cardiogenic Shock Post Myocardial InfarctionRISENCT07655479
Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support
An observational study of Cardiogenic Shock Post Myocardial Infarction, run by University Hospital of Cologne at 3 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 77 years
- Conditions the study is for
- Cardiogenic Shock Post Myocardial Infarction
- What is being tested?
- Escalation to more capable microaxial flow-pump (Impella 5.5)
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 3 sitesGermany
- Study dates
- 23 Apr 2026to Oct 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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%
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
University Hospital Cologne
Cologne, 50937
Sebastian Heyne, Dr. med., +49 221 478 84452, sebastian.heyne@uk-koeln.de
- Recruiting
University Hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Malte Kelm, Prof., +49 211 8118801, kardiologie@med.uni-duesseldorf.de
- Recruiting
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Bernd Panholzer, Dr.med., +49 431 50028193, Bernd.Panholzer@uksh.de
About this study
Official title: 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
Read the 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.
- Being tested
- Escalation to more capable microaxial flow-pump (Impella 5.5)
- Keywords
- Impella, Microaxial Flow-pump, cardiogenic shock, myocardial infarction
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Device Group | Rapid escalation to Impella 5.5 Receives: Device: Escalation to more capable microaxial flow-pump (Impella 5.5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours post revascularization
Secondary outcomes (17)
All-cause mortality
Measured: In-hospital or 30 days post revascularization (whatever comes first)
All-cause mortality
Measured: 180 days post revascularization
Cardiac output
measured by pulmonary artery catheter (PAC) [l/min]
Measured: 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)
Measured: At time of enrolment, 48 hours as well as 72 hours post revascularization.
Lactate
Arterial lactate measured by blood gas analysis [mmol/l]
Measured: 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 [%]
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: At 30 days post revascularization
Time to ambulation
Time to ambulation in hours
Measured: 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
Measured: 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)
Measured: At 30 days and 180 days post revascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start23 Apr 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Shock Post Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Stephan Baldus, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655479
- Sponsor's protocol ID
- 25-1387
- Other IDs
- HORIZON-JU-IHI-2025-09
- Acronym
- RISE
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to data protection regulations and study contracts
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Impella Support and Escalation Trial
- ClinicalTrials.gov ID
- NCT07655479
- Acronym / sponsor ID
- RISE / 25-1387
- Keywords
- Impella, Microaxial Flow-pump, cardiogenic shock, myocardial infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Group | – | Device: Escalation to more capable microaxial flow-pump (Impella 5.5)Rapid escalation to Impella 5.5 |
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
- Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escalation to more capable microaxial flow-pump (Impella 5.5)Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization | Device | Device Group |
Primary outcome
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)
17 secondary outcomes
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.
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.
Time to extubation
Time frame: At 30 days post revascularization
Time to ambulation
Time frame: At 30 days post revascularization
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
Time frame: At 30 days and 180 days post revascularization
Major adverse kidney events (MAKE)
Time frame: At 30 days and 180 days post revascularization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. Due to data protection regulations and study contracts
Related trials for Cardiogenic Shock Post Myocardial Infarction
Not yet recruitingObservational study
Hong Kong Cardiogenic Shock Initiative
Cardiogenic Shock Acute, STEMI - ST Elevation Myocardial Infarction
Not yet recruiting
Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock
Myocardial Infarction (MI), Cardiogenic Shock
Recruiting
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
Cardiogenic Shock
RecruitingPhase 3
Ivabradine in the Acute Management of Cardiogenic Shock
Cardiogenic Shock Post Myocardial Infarction
RecruitingObservational study
Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)
Cardiogenic Shock Acute, Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock Post Myocardial Infarction, run by University Hospital of Cologne at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Heyne, Dr. med. (+4915125364083, sebastian.heyne@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasoactive Hemodynamic Score (VHS) < 5 (time frame: 48 hours post revascularization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.