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
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
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
[{"measure":"all-cause death","timeFrame":"180 days after randomization"}]