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

NCT07762560

Not Yet RecruitingNA

Sponsor: Leipzig Heart Science gGmbH

Conditions: Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute

Interventions: Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, Conventional hemodynamic monitoring, Hemodynamic stabilization

Countries: Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Leipzig, Saxony, Germany