Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock

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

Conditions

• Cardiogenic Shock
• Acute Myocardial Infarction (AMI)
• Heart Failure, Acute

Interventions

DEVICE

Microaxial 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.

DEVICE

Pulmonary artery catheter

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.

PROCEDURE

Conventional 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).

PROCEDURE

Hemodynamic 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 & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Boston Scientific Corporation

  collaborator INDUSTRY

• Heart Center Leipzig - University Hospital

  collaborator OTHER

• Leipzig Heart Science gGmbH

  lead OTHER

Principal Investigators

• Holger Thiele, Prof. Dr. med. · Heart Center Leipzig at University of Leipzig

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2030-10-31

Completion

2037-04-30

Countries

• Germany

Study Locations