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
Leipzig Heart Science gGmbH
Lead sponsor
University of Southern Denmark
Collaborator
Boston Scientific Corporation
Collaborator
Heart Center Leipzig - University Hospital
Collaborator