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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 augustus 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

780

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Apparaat: 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.
Experimenteel: 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.
Apparaat: 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.
Procedure: 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).
Actieve vergelijker: 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.
Apparaat: 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.
Procedure: 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.
Actieve vergelijker: 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.
Procedure: 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).
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
all-cause death
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Lactate clearance
Tijdsspanne: 48 hours
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
48 hours
Time to normalization of lactate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: at 6 and 12 months
death, permanent LVAD/HTx and heart failure hospitalization
at 6 and 12 months
Implantable defibrillator
Tijdsspanne: from date of randomization up to 12 months.
Need for implantable cardiac defibrillator
from date of randomization up to 12 months.
Health-related costs
Tijdsspanne: from date of randomization to 6 months
Health related costs in € for each intervention.
from date of randomization to 6 months
Mortality
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sustained ventricular arrhythmia requiring cardioversion
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: From randomization to 72 hours after randomization
From randomization to 72 hours after randomization
Requirement for renal replacement therapy
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: from date of randomization up to 4 weeks.
from date of randomization up to 4 weeks.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Leipzig Heart Science gGmbH

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2030

Studie voltooiing (Geschat)

1 april 2037

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 augustus 2026

Eerst geplaatst (Werkelijk)

13 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DOUBLE-SHOCK Trial

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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