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

Browse trials for

• Shock, Cardiogenic 296
• Heart Failure 6,331

Keywords

• 2x2 factorial design
• Mortality
• Intensive care
• Percutaneous coronary intervention
• Hemodynamic monitoring
• Mechanical circulatory support
• Impella
• Microaxial flow pump
• AMI-CS
• Acute myocardial infarction
• Cardiogenic shock

Shock, Cardiogenic

296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.

This study's planned enrollment of 780 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.

Lead sponsor

Leipzig Heart Science gGmbH is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Study arms

• 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.

  Device: Microaxial flow pump (left ventricular assist device) · Device: Pulmonary artery catheter

• 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.

  Device: Microaxial flow pump (left ventricular assist device) · Procedure: Conventional hemodynamic monitoring

• Active comparator
  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.

  Device: Pulmonary artery catheter · Procedure: Hemodynamic stabilization

• Active comparator
  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 · Procedure: Hemodynamic stabilization

Interventions

• DeviceMicroaxial 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.

• DevicePulmonary 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.

• ProcedureConventional 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).

• ProcedureHemodynamic 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.

Primary outcomes

1. all-cause death

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

   Time frame: 180 days after randomization

Secondary outcomes

1. Lactate clearance

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

   Time frame: 48 hours

2. Time to normalization of lactate

   Time in hours to stable normalization of arterial lactate \<2 mmol/l.

   Time frame: from date of randomization until the 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

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

   Time frame: from date of randomization up to 4 weeks

5. Vasoactive-inotropic score (VIS)

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

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

6. Need for cardio-pulmonary resuscitation

   Number of patients requiring cardiopulmonary resuscitation.

   Time frame: from date of randomization up to 4 weeks

7. Length of intensive care unit stay

   Length of intensive care unit stay in days

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

8. Length of hospitalization

   Length of hospital stay in days

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

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

   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.

   Time frame: 6month, 12 month after randomisation

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

    Need for heart replacement therapy

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

14. Mortality and heart failure events

    death, permanent LVAD/HTx and heart failure hospitalization

    Time frame: at 6 and 12 months

15. Implantable defibrillator

    Need for implantable cardiac defibrillator

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

16. Health-related costs

    Health related costs in € for each intervention.

    Time frame: from date of randomization to 6 months

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

   Sustained ventricular arrhythmia requiring cardioversion

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

2. Bradycardia with pacing requirement

   Bradycardia requiring pacing.

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

3. Acute kidney injury according to KDIGO criteria

   Acute kidney injury according to KDIGO criteria

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

4. Creatinine clearance (assessed by eGFR)

   Time frame: From randomization to 72 hours after randomization

5. Requirement for renal replacement therapy

   Acute kidney injury requiring renal replacement therapy.

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

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

   Major bleeding according to BARC 3-5 criteria.

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

7. Cumulative transfusion need

   Number of red packed blood cells for transfusion per patient .

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

8. Vascular access site related complications

   Number of vascular access site related complications.

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

9. Significant hemolysis

   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

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

10. Sepsis with positive blood cultures

    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)

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

11. Stroke

    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

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

12. Thrombocytopenia

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

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

13. Device malfunction

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

Individual participant data

Plan to share: No — 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.