Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
15. juni 2026 opdateret af: Stephan Baldus, University Hospital of Cologne
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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
115
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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:
- Hypotension or need for inotropes AND
- Lactate > 2.5 mM AND
- Left ventricular ejection fraction (EF) < 45%
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.
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Device Group
Rapid escalation to Impella 5.5
|
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vasoactive Hemodynamic Score (VHS) < 5
Tidsramme: 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) |
48 hours post revascularization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
All-cause mortality
Tidsramme: In-hospital or 30 days post revascularization (whatever comes first)
|
In-hospital or 30 days post revascularization (whatever comes first)
|
|
|
All-cause mortality
Tidsramme: 180 days post revascularization
|
180 days post revascularization
|
|
|
Cardiac output
Tidsramme: At time of enrolment, 48 hours as well as 72 hours post revascularization.
|
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)
Tidsramme: 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) |
At time of enrolment, 48 hours as well as 72 hours post revascularization.
|
|
Lactate
Tidsramme: At time of enrolment, 48 hours as well as 72 hours post revascularisation
|
Arterial lactate measured by blood gas analysis [mmol/l]
|
At time of enrolment, 48 hours as well as 72 hours post revascularisation
|
|
Perfusion
Tidsramme: At time of enrolment and 48 hours post revascularization.
|
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
Tidsramme: 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)
|
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
Tidsramme: 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
|
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
Tidsramme: At time of enrolment, 48 hours as well as 72 hours post revascularization.
|
Prevalence of clinically relevant haemolysis according to SHARC definitions
|
At time of enrolment, 48 hours as well as 72 hours post revascularization.
|
|
Cerebral events
Tidsramme: 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
|
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)
Tidsramme: 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)
|
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
Tidsramme: 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.
|
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
Tidsramme: 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
|
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
Tidsramme: At 30 days post revascularization
|
Time to extubation in hours
|
At 30 days post revascularization
|
|
Time to ambulation
Tidsramme: At 30 days post revascularization
|
Time to ambulation in hours
|
At 30 days post revascularization
|
|
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
Tidsramme: At 30 days and 180 days post revascularization
|
Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
|
At 30 days and 180 days post revascularization
|
|
Major adverse kidney events (MAKE)
Tidsramme: 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)
|
At 30 days and 180 days post revascularization
|
Samarbejdspartnere og efterforskere
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Datoer for undersøgelser
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Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. oktober 2028
Studieafslutning (Anslået)
1. oktober 2028
Datoer for studieregistrering
Først indsendt
21. april 2026
Først indsendt, der opfyldte QC-kriterier
15. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-1387
- HORIZON-JU-IHI-2025-09 (Andet bevillings-/finansieringsnummer: IHI Joint Undertaking)
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IPD-planbeskrivelse
Due to data protection regulations and study contracts
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