NCT07762560Not yet recruiting
Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 3 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- Oct 2030
- Lead sponsor
- Leipzig Heart Science gGmbH
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07762560
What you commit to
- Study type: Interventional
- Planned participants: 780
- From 1 Oct 2026 to the primary completion date, Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Age \<18 and \>80 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart Center Leipzig at University of Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.