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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- all-cause death
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •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)
- •After 390 included patients with OHCA, any OHCA will be an exclusion criterion
- •Any unwitnessed OHCA
- •Refractory cardiac arrest with ongoing chest compression
- •Evidence of severe right ventricular failure
- •Severe aorta valve regurgitation/stenosis
- •Severe peripheral arterial obstructive disease precluding mAFP placement
- •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
- •Mental disorder or language barrier that preclude informed consent
- •Known pregnancy
Arms & Interventions
Medical therapy + pulmonary artery catheter
Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Intervention: Hemodynamic stabilization (Procedure)
Medical therapy + conventional monitoring
Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated.
Intervention: Conventional hemodynamic monitoring (Procedure)
Microaxial flow pump + pulmonary artery catheter
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Intervention: Microaxial flow pump (left ventricular assist device) (Device)
Microaxial flow pump + pulmonary artery catheter
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Intervention: Pulmonary artery catheter (Device)
Microaxial flow pump + conventional monitoring
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted.
Intervention: Conventional hemodynamic monitoring (Procedure)
Medical therapy + pulmonary artery catheter
Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
Intervention: Pulmonary artery catheter (Device)
Medical therapy + conventional monitoring
Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated.
Intervention: Hemodynamic stabilization (Procedure)
Microaxial flow pump + conventional monitoring
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted.
Intervention: Microaxial flow pump (left ventricular assist device) (Device)
Outcomes
Primary Outcomes
all-cause death
Time Frame: 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 Outcomes
- Lactate clearance(48 hours)
- Time to normalization of lactate(from date of randomization until the 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)
- Vasoactive-inotropic score (VIS)(from randomization to ICU discharge which usually occurs within 4 weeks)
- Need for cardio-pulmonary resuscitation(from date of randomization up to 4 weeks)
- Length of intensive care unit stay(from date of randomization to usually up to 4 weeks.)
- Length of hospitalization(from date of randomization to usually up to 6 months)
- Quality of life (EuroQol 5D-5L)(6month, 12 month after randomisation)
- 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.)
- Mortality and heart failure events(at 6 and 12 months)
- Implantable defibrillator(from date of randomization up to 12 months.)
- Health-related costs(from date of randomization to 6 months)
- Mortality(From randomization to death from any cause, assessed annually up to 10 years after randomization)