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

N/ANot Yet RecruitingNCT07762560

Leipzig Heart Science gGmbH780 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

780

Conditions

Cardiogenic Shock

Interventions

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 catheterDEVICE

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 monitoringPROCEDURE

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 stabilizationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Lactate clearance

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

Time frame: 48 hours

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.

Time to hemodynamic stabilization

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

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

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

Need for cardio-pulmonary resuscitation

Number of patients requiring cardiopulmonary resuscitation.

Time frame: from date of randomization up to 4 weeks

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.

Length of hospitalization

Length of hospital stay in days

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

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

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

Time to rehospitalization for congestive heart failure

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

Time to death

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

Use of heart replacement therapy

Need for heart replacement therapy

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

Mortality and heart failure events

death, permanent LVAD/HTx and heart failure hospitalization

Time frame: at 6 and 12 months

Implantable defibrillator

Need for implantable cardiac defibrillator

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

Health-related costs

Health related costs in € for each intervention.

Time frame: from date of randomization to 6 months

Mortality

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