Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support (RISE)
15. Juni 2026 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
115
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Device Group
Rapid escalation to Impella 5.5
|
Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Vasoactive Hemodynamic Score (VHS) < 5
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
All-cause mortality
Zeitfenster: In-hospital or 30 days post revascularization (whatever comes first)
|
In-hospital or 30 days post revascularization (whatever comes first)
|
|
|
All-cause mortality
Zeitfenster: 180 days post revascularization
|
180 days post revascularization
|
|
|
Cardiac output
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At 30 days post revascularization
|
Time to extubation in hours
|
At 30 days post revascularization
|
|
Time to ambulation
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Oktober 2028
Studienabschluss (Geschätzt)
1. Oktober 2028
Studienanmeldedaten
Zuerst eingereicht
21. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Juni 2026
Zuerst gepostet (Tatsächlich)
17. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 25-1387
- HORIZON-JU-IHI-2025-09 (Andere Zuschuss-/Finanzierungsnummer: IHI Joint Undertaking)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Due to data protection regulations and study contracts
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .