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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 actualizado 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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

De observación

Inscripción (Estimado)

115

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Cologne, Alemania, 50937
        • Reclutamiento
        • University Hospital Cologne
        • Contacto:
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemania, 40225
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Alemania, 24105
        • Reclutamiento
        • University Hospital Schleswig-Holstein, Campus Kiel
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vasoactive Hemodynamic Score (VHS) < 5
Periodo de tiempo: 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 resultado secundarias

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital of Cologne

Colaboradores

Johnson & Johnson

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de abril de 2026

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 25-1387
  • HORIZON-JU-IHI-2025-09 (Otro número de subvención/financiamiento: IHI Joint Undertaking)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Due to data protection regulations and study contracts

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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