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| ID | Type | Description | Link |
|---|---|---|---|
| HORIZON-JU-IHI-2025-09 | Other Grant/Funding Number | IHI Joint Undertaking |
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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Group | Rapid escalation to Impella 5.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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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:
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
Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Heyne, Dr. med. | Contact | +4915125364083 | sebastian.heyne@uk-koeln.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Cologne | Recruiting | Cologne | 50937 | Germany |
Due to data protection regulations and study contracts
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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 |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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