← Back to all trials
Not Yet Recruiting
NCT07762560
Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock
Conditions: Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 780
Sponsor: Leipzig Heart Science gGmbH
Location: Heart Center Leipzig at University of Leipzig Leipzig Saxony
Summary
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 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 \90 mmHg during systole
3. Arterial lactate \>2.0 mmol/L
4. Echocardiogram with LVEF \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 \
Source: ClinicalTrials.gov (NCT07762560). StuddyBuddy aggregates publicly available trial information.