Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
15. června 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Pozorovací
Zápis (Odhadovaný)
115
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Device Group
Rapid escalation to Impella 5.5
|
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Vasoactive Hemodynamic Score (VHS) < 5
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
All-cause mortality
Časové okno: In-hospital or 30 days post revascularization (whatever comes first)
|
In-hospital or 30 days post revascularization (whatever comes first)
|
|
|
All-cause mortality
Časové okno: 180 days post revascularization
|
180 days post revascularization
|
|
|
Cardiac output
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At 30 days post revascularization
|
Time to extubation in hours
|
At 30 days post revascularization
|
|
Time to ambulation
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. října 2028
Dokončení studie (Odhadovaný)
1. října 2028
Termíny zápisu do studia
První předloženo
21. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
15. června 2026
První zveřejněno (Aktuální)
17. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-1387
- HORIZON-JU-IHI-2025-09 (Jiné číslo grantu/financování: IHI Joint Undertaking)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Due to data protection regulations and study contracts
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .