Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute
Conditions
Keywords
2x2 factorial design, Mortality, Intensive care, Percutaneous coronary intervention, Hemodynamic monitoring, Mechanical circulatory support, Impella, Microaxial flow pump, AMI-CS, Acute myocardial infarction, Cardiogenic shock
Brief 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
Interventions
DEVICEMicroaxial flow pump (left ventricular assist device)
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
PROCEDUREConventional hemodynamic monitoring
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
PROCEDUREHemodynamic stabilization
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
Sponsors
Leipzig Heart Science gGmbH
University of Southern Denmark
Boston Scientific Corporation
Heart Center Leipzig - University Hospital
Stiftung Institut fuer Herzinfarktforschung
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause death | 180 days after randomization | The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lactate clearance | 48 hours | Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement. |
| Time to normalization of lactate | from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l. | Time in hours to stable normalization of arterial lactate \<2 mmol/l. |
| Time to hemodynamic stabilization | Time to hemodynamic stabilization from randomization up to 4 weeks. | — |
| Need for escalation to (additional) MCS | from date of randomization up to 4 weeks | Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks. |
| Vasoactive-inotropic score (VIS) | from randomization to ICU discharge which usually occurs within 4 weeks | The score has no metric; higher values indicate worse outcomes. |
| Need for cardio-pulmonary resuscitation | from date of randomization up to 4 weeks | Number of patients requiring cardiopulmonary resuscitation. |
| Length of intensive care unit stay | from date of randomization to usually up to 4 weeks. | Length of intensive care unit stay in days |
| Length of hospitalization | from date of randomization to usually up to 6 months | Length of hospital stay in days |
| Quality of life (EuroQol 5D-5L) | 6month, 12 month after randomisation | Quality of life measured by the EuroQol 5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
| Time to recurrent myocardial infarction | From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization | — |
| Time to rehospitalization for congestive heart failure | during the first 30 days, 6 and 12 months after randomization | — |
| Time to death | during the first 30 days and 12 months after randomization | — |
| Use of heart replacement therapy | from date of randomization up to 6 months. | Need for heart replacement therapy |
| Mortality and heart failure events | at 6 and 12 months | death, permanent LVAD/HTx and heart failure hospitalization |
| Implantable defibrillator | from date of randomization up to 12 months. | Need for implantable cardiac defibrillator |
| Health-related costs | from date of randomization to 6 months | Health related costs in € for each intervention. |
| Mortality | From randomization to death from any cause, assessed annually up to 10 years after randomization | — |
Countries
Germany
Contacts
CONTACTDOUBLE SHOCK Leipzig Heart Science gGmbH
PRINCIPAL_INVESTIGATORHolger Thiele, Prof. Dr. med.
Heart Center Leipzig at University of Leipzig
PRINCIPAL_INVESTIGATORJacob Eifer Møller, Prof DMSc
Copenhagen University Hospital Righospitalet
PRINCIPAL_INVESTIGATORChristian Hassager, Prof. DMSc
Rigshospitalet, Denmark
PRINCIPAL_INVESTIGATORAnne Freund, PD Dr. med.
Heart Center Leipzig at Leipzig University
Outcome results
None listed