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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)

24 de agosto de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Observacional

Inscrição (Estimado)

115

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Alemanha
      • Cologne, Alemanha, 50937
        • Recrutamento
        • University Hospital Cologne
        • Contato:
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemanha, 40225
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Alemanha, 24105
        • Recrutamento
        • University Hospital Schleswig-Holstein, Campus Kiel
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Vasoactive Hemodynamic Score (VHS) < 5
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
All-cause mortality
Prazo: In-hospital or 30 days post revascularization (whatever comes first)
In-hospital or 30 days post revascularization (whatever comes first)
All-cause mortality
Prazo: 180 days post revascularization
180 days post revascularization
Cardiac output
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: At 30 days post revascularization
Time to extubation in hours
At 30 days post revascularization
Time to ambulation
Prazo: 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
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital of Cologne

Colaboradores

Johnson & Johnson

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de abril de 2026

Conclusão Primária (Estimado)

1 de outubro de 2028

Conclusão do estudo (Estimado)

1 de outubro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 25-1387
  • HORIZON-JU-IHI-2025-09 (Número de outro subsídio/financiamento: IHI Joint Undertaking)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Due to data protection regulations and study contracts

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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