Heart pump and monitoring tests in heart attack patients with cardiogenic shock

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 with cardiogenic shock (the heart cannot pump enough blood) caused by a heart attack. It compares a heart pump and catheter-based monitoring with standard care.

Age

18 to 80 years

Sex

All sexes can join.

Disease stage

Heart attack (STEMI or NSTEMI) with cardiogenic shock. Planned immediate angiography and revascularization (preferably PCI). Systolic blood pressure <100 mmHg or catecholamines needed to keep it above 90 mmHg. Arterial lactate >2.0 mmol/L. Heart ultrasound showing LVEF <40% or LVOT-VTI ≤12 cm (4.7 in).

Biomarker or test result

Arterial lactate >2.0 mmol/L; LVEF <40% or LVOT-VTI ≤12 cm (4.7 in) on heart ultrasound.

Main reasons for not taking part

• Shock lasting more than 12 hours
• Shock from other causes (low blood volume, sepsis, pulmonary embolism, anaphylaxis) or from a mechanical complication of the heart attack
• Cardiac arrest with ongoing chest compression, or an unwitnessed cardiac arrest outside hospital
• Severe right heart failure, severe aortic valve disease, or a mechanical aortic valve
• Known pregnancy

The registry criteria, word for word

Check if you might fit

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?YesNo

What the trial wants to find out

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 4 groups in the trial

• Microaxial flow pump + pulmonary artery catheterTreatment being tested

  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.

  Treatment: Microaxial flow pump (left ventricular assist device) and Pulmonary artery catheter

• Microaxial flow pump + conventional monitoringTreatment being tested

  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.

  Treatment: Microaxial flow pump (left ventricular assist device) and Conventional hemodynamic monitoring

• Medical therapy + pulmonary artery catheterExisting treatment, for comparison

  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.

  Treatment: Pulmonary artery catheter and Hemodynamic stabilization

• Medical therapy + conventional monitoringExisting treatment, for comparison

  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.

  Treatment: Conventional hemodynamic monitoring and Hemodynamic stabilization