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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 sierpnia 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

780

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Urządzenie: 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.
Eksperymentalny: 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.
Urządzenie: 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.
Procedura: 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).
Aktywny 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.
Urządzenie: 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.
Procedura: 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.
Aktywny 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.
Procedura: 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).
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
all-cause death
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Sustained ventricular arrhythmia requiring cardioversion
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: From randomization to 72 hours after randomization
From randomization to 72 hours after randomization
Requirement for renal replacement therapy
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: from date of randomization up to 4 weeks.
from date of randomization up to 4 weeks.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Leipzig Heart Science gGmbH

Współpracownicy

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

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 października 2030

Ukończenie studiów (Szacowany)

1 kwietnia 2037

Daty rejestracji na studia

Pierwszy przesłany

3 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

13 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DOUBLE-SHOCK Trial

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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