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Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock (DOUBLE-SHOCK)

20. August 2026 aktualisiert von: Leipzig Heart Science gGmbH

Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock

The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).

The main questions it aims to answer are:

  • Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?
  • Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?

Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:

  • Microaxial flow pump + pulmonary artery catheter
  • Microaxial flow pump + conventional monitoring
  • Medical therapy alone + pulmonary artery catheter
  • Medical therapy alone + conventional monitoring

Participants will:

  • Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups
  • Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI
  • Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring
  • Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

780

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Deutschland
    • Saxony
      • Leipzig, Saxony, Deutschland, 04289
        • Heart Center Leipzig at University of Leipzig

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

Beschreibung

Inclusion Criteria:

Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:

  1. Planned immediate angiography and revascularization (preferred PCI)
  2. Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
  3. Arterial lactate >2.0 mmol/L
  4. Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm

Exclusion Criteria:

  1. Age <18 and >80 years
  2. Shock duration >12 hours
  3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
  4. Shock due to mechanical complication of AMI
  5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression >10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression <10 min are also eligible)
  6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion
  7. Any unwitnessed OHCA
  8. Refractory cardiac arrest with ongoing chest compression
  9. Evidence of severe right ventricular failure
  10. Severe aorta valve regurgitation/stenosis
  11. Severe peripheral arterial obstructive disease precluding mAFP placement
  12. Abnormalities of the aorta precluding mAFP device placement
  13. Presence of a mechanical aortic valve prosthesis
  14. Left ventricular thrombus
  15. Infective endocarditis
  16. Life expectancy <1 year due to comorbidities
  17. Mental disorder or language barrier that preclude informed consent
  18. Known pregnancy

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Microaxial flow pump + pulmonary artery catheter
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Gerät: Microaxial flow pump (left ventricular assist device)
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Gerät: Pulmonary artery catheter
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Experimental: Microaxial flow pump + conventional monitoring
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted.
Gerät: Microaxial flow pump (left ventricular assist device)
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Verfahren: Conventional hemodynamic monitoring
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Aktiver Komparator: Medical therapy + pulmonary artery catheter
Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Gerät: Pulmonary artery catheter
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Verfahren: Hemodynamic stabilization
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
Aktiver Komparator: Medical therapy + conventional monitoring
Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated.
Verfahren: Conventional hemodynamic monitoring
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Verfahren: Hemodynamic stabilization
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
all-cause death
Zeitfenster: 180 days after randomization
The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.
180 days after randomization

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Lactate clearance
Zeitfenster: 48 hours
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
48 hours
Time to normalization of lactate
Zeitfenster: from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time in hours to stable normalization of arterial lactate <2 mmol/l.
from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time to hemodynamic stabilization
Zeitfenster: Time to hemodynamic stabilization from randomization up to 4 weeks.
Time to hemodynamic stabilization from randomization up to 4 weeks.
Need for escalation to (additional) MCS
Zeitfenster: from date of randomization up to 4 weeks
Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
from date of randomization up to 4 weeks
Vasoactive-inotropic score (VIS)
Zeitfenster: from randomization to ICU discharge which usually occurs within 4 weeks
The score has no metric; higher values indicate worse outcomes.
from randomization to ICU discharge which usually occurs within 4 weeks
Need for cardio-pulmonary resuscitation
Zeitfenster: from date of randomization up to 4 weeks
Number of patients requiring cardiopulmonary resuscitation.
from date of randomization up to 4 weeks
Length of intensive care unit stay
Zeitfenster: from date of randomization to usually up to 4 weeks.
Length of intensive care unit stay in days
from date of randomization to usually up to 4 weeks.
Length of hospitalization
Zeitfenster: from date of randomization to usually up to 6 months
Length of hospital stay in days
from date of randomization to usually up to 6 months
Quality of life (EuroQol 5D-5L)
Zeitfenster: 6month, 12 month after randomisation
Quality of life measured by the EuroQol 5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
6month, 12 month after randomisation
Time to recurrent myocardial infarction
Zeitfenster: From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
Time to rehospitalization for congestive heart failure
Zeitfenster: during the first 30 days, 6 and 12 months after randomization
during the first 30 days, 6 and 12 months after randomization
Time to death
Zeitfenster: during the first 30 days and 12 months after randomization
during the first 30 days and 12 months after randomization
Use of heart replacement therapy
Zeitfenster: from date of randomization up to 6 months.
Need for heart replacement therapy
from date of randomization up to 6 months.
Mortality and heart failure events
Zeitfenster: at 6 and 12 months
death, permanent LVAD/HTx and heart failure hospitalization
at 6 and 12 months
Implantable defibrillator
Zeitfenster: from date of randomization up to 12 months.
Need for implantable cardiac defibrillator
from date of randomization up to 12 months.
Health-related costs
Zeitfenster: from date of randomization to 6 months
Health related costs in € for each intervention.
from date of randomization to 6 months
Mortality
Zeitfenster: From randomization to death from any cause, assessed annually up to 10 years after randomization
From randomization to death from any cause, assessed annually up to 10 years after randomization

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sustained ventricular arrhythmia requiring cardioversion
Zeitfenster: from date of randomization up to usually 4 weeks
Sustained ventricular arrhythmia requiring cardioversion
from date of randomization up to usually 4 weeks
Bradycardia with pacing requirement
Zeitfenster: from date of randomization up to usually 4 weeks.
Bradycardia requiring pacing.
from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
Zeitfenster: from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
from date of randomization up to usually 4 weeks.
Creatinine clearance (assessed by eGFR)
Zeitfenster: From randomization to 72 hours after randomization
From randomization to 72 hours after randomization
Requirement for renal replacement therapy
Zeitfenster: from date of randomization up to usually 4 weeks.
Acute kidney injury requiring renal replacement therapy.
from date of randomization up to usually 4 weeks.
Major bleeding according to BARC definition (BARC 3-5)
Zeitfenster: from date of randomization up to usually 4 weeks
Major bleeding according to BARC 3-5 criteria.
from date of randomization up to usually 4 weeks
Cumulative transfusion need
Zeitfenster: from date of randomization up to 4 weeks.
Number of red packed blood cells for transfusion per patient .
from date of randomization up to 4 weeks.
Vascular access site related complications
Zeitfenster: from date of randomization up to 4 weeks.
Number of vascular access site related complications.
from date of randomization up to 4 weeks.
Significant hemolysis
Zeitfenster: from date of randomization up to usually 4 weeks.

Significant hemolysis is defined as a plasma free hemoglobin >20 mg/dL (or an increase of 20 mg/dL above baseline values before initiation of support) and at least one of the following clinical findings occurring within 72 hours after initiation of support or within 24 (±2) hours of device removal:

  • Presence of hemoglobinuria ("tea-colored urine") with exclusion of gross hematuria
  • New or worsening anemia defined as an absolute decrease in hematocrit by 10% or hemoglobin level by 3 g/dL not explained by other clinical factors.
  • Hyperbilirubinemia defined as a total bilirubin above 2 mg/dl (predominately indirect component)
  • Creatinine increasing by greater than 50% above baseline or the need for new dialysis not explained by other clinical factors.
  • Device malfunction or abnormal pump parameters
from date of randomization up to usually 4 weeks.
Sepsis with positive blood cultures
Zeitfenster: from date of randomization up to usually 4 weeks.

Sepsis is defined as: Sepsis is caused by the immune system's response to a serious infection, most commonly bacteria, but also fungi, viruses, and parasites in the blood, urinary tract, lungs, skin, or other tissues. It will be defined as:

Positive blood cultures and two or more of the following (SEPSIS-3 criteria):

  1. Low blood pressure (SBP ≤100 mmHg),
  2. High respiratory rate (≥22 breaths per min), or
  3. Altered mentation (Glasgow coma scale <15) (quick SOFA)
from date of randomization up to usually 4 weeks.
Stroke
Zeitfenster: from date of randomization up to usually 4 weeks.

Stroke will be classified in hemorrhagic (cranial CT, MRI, or autopsy) or non-hemorrhagic.

Stroke is defined as an acute new neurological deficit ending in death or lasting longer than 24 hours, and classified by a physician as a stroke.

  1. Primary hemorrhagic - defined as an intracerebral hemorrhage or subdural hematoma

    1. Intracerebral hemorrhage - Stroke with focal collections of intracerebral blood seen on brain imaging (CT or MRI) or a post-mortem examination, not felt to represent hemorrhagic conversion. Subarachnoid hemorrhage should be included in this category.
    2. Subdural hematoma - High density fluid collection in subdural space on brain images or blood in the subdural space on autopsy.
  2. Non-hemorrhagic cerebral infarction - Stroke without focal collections of intracerebral blood on brain imaging.
  3. Non-hemorrhagic infarction with hemorrhagic conversion - Cerebral infarction with blood felt to represent hemorrhagic
from date of randomization up to usually 4 weeks.
Thrombocytopenia
Zeitfenster: from date of randomization up to 4 weeks.
Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.
from date of randomization up to 4 weeks.
Device malfunction
Zeitfenster: from date of randomization up to 4 weeks.
from date of randomization up to 4 weeks.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Leipzig Heart Science gGmbH

Mitarbeiter

Boston Scientific Corporation
University of Southern Denmark
Heart Center Leipzig - University Hospital
Stiftung Institut fuer Herzinfarktforschung

Ermittler

  • Hauptermittler: Holger Thiele, Prof. Dr. med., Heart Center Leipzig at University of Leipzig
  • Hauptermittler: Jacob Eifer Møller, Prof DMSc, Copenhagen University Hospital Righospitalet
  • Hauptermittler: Christian Hassager, Prof. DMSc, Rigshospitalet, Denmark
  • Hauptermittler: Anne Freund, PD Dr. med., Heart Center Leipzig at Leipzig University

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. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2030

Studienabschluss (Geschätzt)

1. April 2037

Studienanmeldedaten

Zuerst eingereicht

3. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. August 2026

Zuerst gepostet (Tatsächlich)

13. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • DOUBLE-SHOCK Trial

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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