An observational study in Cardiogenic Shock Post Myocardial Infarction, sponsored by University Hospital of Cologne. Recruiting at 3 sites in Germany. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University Hospital of Cologne · Observational
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
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.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's planned enrollment of 115 is below the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →University Hospital of Cologne is the lead sponsor of 42 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Exclusion Criteria:
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
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)
Time frame: 48 hours post revascularization
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
measured by pulmonary artery catheter (PAC) \[l/min\]
Time frame: 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)
Time frame: At time of enrolment, 48 hours as well as 72 hours post revascularization.
Lactate
Arterial lactate measured by blood gas analysis \[mmol/l\]
Time frame: 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 \[%\]
Time frame: 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)
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
Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair
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
Prevalence of clinically relevant haemolysis according to SHARC definitions
Time frame: 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
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)
Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)
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
Access site infection with the need to surgical intervention
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 to extubation in hours
Time frame: At 30 days post revascularization
Time to ambulation
Time to ambulation in hours
Time frame: 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
Time frame: 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)
Time frame: At 30 days and 180 days post revascularization
Plan to share: No — Due to data protection regulations and study contracts
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University Hospital of Cologne