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Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)

15 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

115

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Device Group
Rapid escalation to Impella 5.5
Dispositivo: Escalation to more capable microaxial flow-pump (Impella 5.5)
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Vasoactive Hemodynamic Score (VHS) < 5
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality
Lasso di tempo: In-hospital or 30 days post revascularization (whatever comes first)
In-hospital or 30 days post revascularization (whatever comes first)
All-cause mortality
Lasso di tempo: 180 days post revascularization
180 days post revascularization
Cardiac output
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At 30 days post revascularization
Time to extubation in hours
At 30 days post revascularization
Time to ambulation
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital of Cologne

Collaboratori

Johnson & Johnson

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-1387
  • HORIZON-JU-IHI-2025-09 (Altro numero di sovvenzione/finanziamento: IHI Joint Undertaking)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Due to data protection regulations and study contracts

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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