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
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
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
Factorial
Microaxial flow pump (left ventricular assist device)
DevicePercutaneous 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
DeviceInsertion 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/SurgeryStandard 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/SurgeryHemodynamic 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.
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.
Lactate clearance
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
Time to normalization of lactate
Time in hours to stable normalization of arterial lactate \<2 mmol/l.
Time to hemodynamic stabilization
Need for escalation to (additional) MCS
Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
Sustained ventricular arrhythmia requiring cardioversion
Sustained ventricular arrhythmia requiring cardioversion
Bradycardia with pacing requirement
Bradycardia requiring pacing.
Acute kidney injury according to KDIGO criteria
Acute kidney injury according to KDIGO criteria
Creatinine clearance (assessed by eGFR)
Click on the lead sponsor to view all of their trials.
Leipzig Heart Science gGmbH
Lead sponsor
University of Southern Denmark
Collaborator
Boston Scientific Corporation
Collaborator
Heart Center Leipzig - University Hospital
Collaborator
Stiftung Institut fuer Herzinfarktforschung
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
