Cardiogenic Shock Post Myocardial Infarction
Conditions
Keywords
Impella, Microaxial Flow-pump, cardiogenic shock, myocardial infarction
Brief 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 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.
Interventions
DEVICEEscalation to more capable microaxial flow-pump (Impella 5.5)
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
Sponsors
University Hospital of Cologne
Johnson & Johnson
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasoactive Hemodynamic Score (VHS) < 5 | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury (AKI) | 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) |
| 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 | 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 |
| Time to extubation | At 30 days post revascularization | Time to extubation in hours |
| Time to ambulation | At 30 days post revascularization | Time to ambulation in hours |
| Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant | At 30 days and 180 days post revascularization | Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant |
| Major adverse kidney events (MAKE) | 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) |
| All-cause mortality | In-hospital or 30 days post revascularization (whatever comes first) | — |
| Cardiac output | At time of enrolment, 48 hours as well as 72 hours post revascularization. | measured by pulmonary artery catheter (PAC) \[l/min\] |
| Vasoactive-Inotropic Score (VIS) | 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) |
| Lactate | At time of enrolment, 48 hours as well as 72 hours post revascularisation | Arterial lactate measured by blood gas analysis \[mmol/l\] |
| Perfusion | At time of enrolment and 48 hours post revascularization. | Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements \[%\] |
| Major 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. | Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding) |
| Ischemia of the extremities | 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 |
| Cerebral events | 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 |
| Haemolysis | At time of enrolment, 48 hours as well as 72 hours post revascularization. | Prevalence of clinically relevant haemolysis according to SHARC definitions |
Countries
Germany
Contacts
CONTACTSebastian Heyne, Dr. med.
Outcome results
None listed