Heart pump and monitoring tests in heart attack patients with cardiogenic shock
Tests a heart pump and catheter monitoring in adults with heart attack-related cardiogenic shock.
Plain-language title generated from the registry record
Registry title: Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock
Key facts
- Where
- Leipzig, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07762560, who can take part
Where in Germany
- Heart Center Leipzig at University of LeipzigLeipzig, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leipzig Heart Science gGmbH
- Trial code
- NCT07762560
- Record updated
- 9 November 2026
- Original description
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).Read full original descriptionShow less
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: Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:; 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.
Exclusion: 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); Refractory cardiac arrest with ongoing chest compression; Evidence of severe right ventricular failure; Severe peripheral arterial obstructive disease precluding mAFP placement; Mental disorder or language barrier that preclude informed consent; 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; After 390 included patients with OHCA, any OHCA will be an exclusion criterion; Any unwitnessed OHCA; Severe aorta valve regurgitation/stenosis; Abnormalities of the aorta precluding mAFP device placement; Presence of a mechanical aortic valve prosthesis; Left ventricular thrombus; Infective endocarditis; Life expectancy <1 year due to comorbidities; Known pregnancy.