Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07762560

Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cardiogenic Shock Acute Myocardial Infarction (AMI) Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Acute Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

  • Age <18 and >80 years
  • Shock duration >12 hours
  • Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
  • Shock due to mechanical complication of AMI
  • 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)
  • After 390 included patients with OHCA, any OHCA will be an exclusion criterion
  • Any unwitnessed OHCA
  • Refractory cardiac arrest with ongoing chest compression
  • Evidence of severe right ventricular failure
  • Severe aorta valve regurgitation/stenosis
  • Severe peripheral arterial obstructive disease precluding mAFP placement
  • Abnormalities of the aorta precluding mAFP device placement
  • Presence of a mechanical aortic valve prosthesis
  • Left ventricular thrombus
  • Infective endocarditis
  • Life expectancy <1 year due to comorbidities
  • Mental disorder or language barrier that preclude informed consent
  • Known pregnancy

Treatment and study plan

Microaxial flow pump (left ventricular assist device)

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.

Pulmonary Artery Catheter

Device

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.

Conventional hemodynamic monitoring

Procedure

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).

Hemodynamic stabilization

Procedure

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.

Primary outcomes

  1. all-cause death

    Time frame: 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.

Secondary outcomes

  1. Lactate clearance

    Time frame: 48 hours

    Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.

  2. Time to normalization of lactate

    Time frame: 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.

  3. Time to hemodynamic stabilization

    Time frame: Time to hemodynamic stabilization from randomization up to 4 weeks.

  4. Need for escalation to (additional) MCS

    Time frame: from date of randomization up to 4 weeks

    Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.

  5. Vasoactive-inotropic score (VIS)

    Time frame: from randomization to ICU discharge which usually occurs within 4 weeks

    The score has no metric; higher values indicate worse outcomes.

  6. Need for cardio-pulmonary resuscitation

    Time frame: from date of randomization up to 4 weeks

    Number of patients requiring cardiopulmonary resuscitation.

  7. Length of intensive care unit stay

    Time frame: from date of randomization to usually up to 4 weeks.

    Length of intensive care unit stay in days

  8. Length of hospitalization

    Time frame: from date of randomization to usually up to 6 months

    Length of hospital stay in days

  9. Quality of life (EuroQol 5D-5L)

    Time frame: 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.

  10. Time to recurrent myocardial infarction

    Time frame: From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization

  11. Time to rehospitalization for congestive heart failure

    Time frame: during the first 30 days, 6 and 12 months after randomization

  12. Time to death

    Time frame: during the first 30 days and 12 months after randomization

  13. Use of heart replacement therapy

    Time frame: from date of randomization up to 6 months.

    Need for heart replacement therapy

  14. Mortality and heart failure events

    Time frame: at 6 and 12 months

    death, permanent LVAD/HTx and heart failure hospitalization

  15. Implantable defibrillator

    Time frame: from date of randomization up to 12 months.

    Need for implantable cardiac defibrillator

  16. Health-related costs

    Time frame: from date of randomization to 6 months

    Health related costs in € for each intervention.

  17. Mortality

    Time frame: From randomization to death from any cause, assessed annually up to 10 years after randomization

Other outcomes

  1. Sustained ventricular arrhythmia requiring cardioversion

    Time frame: from date of randomization up to usually 4 weeks

    Sustained ventricular arrhythmia requiring cardioversion

  2. Bradycardia with pacing requirement

    Time frame: from date of randomization up to usually 4 weeks.

    Bradycardia requiring pacing.

  3. Acute kidney injury according to KDIGO criteria

    Time frame: from date of randomization up to usually 4 weeks.

    Acute kidney injury according to KDIGO criteria

  4. Creatinine clearance (assessed by eGFR)

    Time frame: From randomization to 72 hours after randomization

  5. Requirement for renal replacement therapy

    Time frame: from date of randomization up to usually 4 weeks.

    Acute kidney injury requiring renal replacement therapy.

  6. Major bleeding according to BARC definition (BARC 3-5)

    Time frame: from date of randomization up to usually 4 weeks

    Major bleeding according to BARC 3-5 criteria.

  7. Cumulative transfusion need

    Time frame: from date of randomization up to 4 weeks.

    Number of red packed blood cells for transfusion per patient .

  8. Vascular access site related complications

    Time frame: from date of randomization up to 4 weeks.

    Number of vascular access site related complications.

  9. Significant hemolysis

    Time frame: 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

  10. Sepsis with positive blood cultures

    Time frame: 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):

    • Low blood pressure (SBP ≤100 mmHg),
    • High respiratory rate (≥22 breaths per min), or
    • Altered mentation (Glasgow coma scale <15) (quick SOFA)

  11. Stroke

    Time frame: 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.

    • Primary hemorrhagic - defined as an intracerebral hemorrhage or subdural hematoma
    • 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.
    • Subdural hematoma - High density fluid collection in subdural space on brain images or blood in the subdural space on autopsy.
    • Non-hemorrhagic cerebral infarction - Stroke without focal collections of intracerebral blood on brain imaging.
    • Non-hemorrhagic infarction with hemorrhagic conversion - Cerebral infarction with blood felt to represent hemorrhagic

  12. Thrombocytopenia

    Time frame: from date of randomization up to 4 weeks.

    Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.

  13. Device malfunction

    Time frame: from date of randomization up to 4 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

DOUBLE SHOCK Leipzig Heart Science gGmbH

CONTACT

[email protected]

+49 341 865 251542

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

  • Boston Scientific Corporation
  • Heart Center Leipzig - University Hospital
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: DOUBLE-SHOCK

Important dates

Study start
2026
Primary completion
2030
Study completion
2037
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.