Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
24 sierpnia 2026 zaktualizowane przez: 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
Przegląd badań
Status
Rekrutacyjny
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
115
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Sebastian Heyne, Dr. med.
- Numer telefonu: +4915125364083
- E-mail: sebastian.heyne@uk-koeln.de
Lokalizacje studiów
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Cologne, Niemcy, 50937
- Rekrutacyjny
- University Hospital Cologne
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Kontakt:
- Sebastian Heyne, Dr. med.
- Numer telefonu: +49 221 478 84452
- E-mail: sebastian.heyne@uk-koeln.de
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Niemcy, 40225
- Rekrutacyjny
- University Hospital Düsseldorf
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Kontakt:
- Malte Kelm, Prof.
- Numer telefonu: +49 211 8118801
- E-mail: kardiologie@med.uni-duesseldorf.de
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Niemcy, 24105
- Rekrutacyjny
- University Hospital Schleswig-Holstein, Campus Kiel
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Kontakt:
- Bernd Panholzer, Dr.med.
- Numer telefonu: +49 431 50028193
- E-mail: Bernd.Panholzer@uksh.de
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Device Group
Rapid escalation to Impella 5.5
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Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Vasoactive Hemodynamic Score (VHS) < 5
Ramy czasowe: 48 hours post revascularization
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
All-cause mortality
Ramy czasowe: In-hospital or 30 days post revascularization (whatever comes first)
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In-hospital or 30 days post revascularization (whatever comes first)
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All-cause mortality
Ramy czasowe: 180 days post revascularization
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180 days post revascularization
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Cardiac output
Ramy czasowe: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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measured by pulmonary artery catheter (PAC) [l/min]
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Vasoactive-Inotropic Score (VIS)
Ramy czasowe: 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.
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Lactate
Ramy czasowe: At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Arterial lactate measured by blood gas analysis [mmol/l]
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At time of enrolment, 48 hours as well as 72 hours post revascularisation
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Perfusion
Ramy czasowe: At time of enrolment and 48 hours post revascularization.
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Enhanced perfusion of the limb used for Impella CP™ access by comparing NIRS measurements [%]
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At time of enrolment and 48 hours post revascularization.
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Major Bleeding
Ramy czasowe: 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.
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Either according to BARC classification (BARC ≥ IIIa) or GUSTO classification (at least moderate bleeding)
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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.
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Ischemia of the extremities
Ramy czasowe: 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.
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Peripheral vascular ischemia (femoral and axillary) with indication to percutaneous intervention or surgical repair
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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.
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Haemolysis
Ramy czasowe: At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Prevalence of clinically relevant haemolysis according to SHARC definitions
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At time of enrolment, 48 hours as well as 72 hours post revascularization.
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Cerebral events
Ramy czasowe: 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.
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Cerebral ischemia or cerebral bleeding assessed via standard-of-care neurological assessment and/or imaging
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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.
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Acute kidney injury (AKI)
Ramy czasowe: 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.
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Acute kidney injury (AKIN level 2 or greater) and/or need for renal replacement therapy (RRT)
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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.
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Sepsis with positive blood culture
Ramy czasowe: 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.
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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.
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Access site infection
Ramy czasowe: 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.
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Access site infection with the need to surgical intervention
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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.
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Time to extubation
Ramy czasowe: At 30 days post revascularization
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Time to extubation in hours
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At 30 days post revascularization
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Time to ambulation
Ramy czasowe: At 30 days post revascularization
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Time to ambulation in hours
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At 30 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
Ramy czasowe: At 30 days and 180 days post revascularization
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Cumulative incidence of escalation to VA-ECMO, LVAD or heart transplant
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At 30 days and 180 days post revascularization
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Major adverse kidney events (MAKE)
Ramy czasowe: At 30 days and 180 days post revascularization
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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)
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At 30 days and 180 days post revascularization
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
23 kwietnia 2026
Zakończenie podstawowe (Szacowany)
1 października 2028
Ukończenie studiów (Szacowany)
1 października 2028
Daty rejestracji na studia
Pierwszy przesłany
21 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
15 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
17 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
27 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25-1387
- HORIZON-JU-IHI-2025-09 (Inny numer grantu/finansowania: IHI Joint Undertaking)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Due to data protection regulations and study contracts
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .