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

NCT07762560 | Not Yet Recruiting

• 1 other identifier: DOUBLE-SHOCK Trial
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• all-cause death

  The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.

  180 days after randomization

Secondary Outcomes (17)

• 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

Other Outcomes (13)

• Sustained ventricular arrhythmia requiring cardioversion

  from date of randomization up to usually 4 weeks

• Bradycardia with pacing requirement

  from date of randomization up to usually 4 weeks.

• Acute kidney injury according to KDIGO criteria

  from date of randomization up to usually 4 weeks.

Study Arms (4)

Microaxial flow pump + pulmonary artery catheter

EXPERIMENTAL

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.

Device: Microaxial flow pump (left ventricular assist device); Device: Pulmonary artery catheter

Microaxial flow pump + conventional monitoring

EXPERIMENTAL

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.

Device: Microaxial flow pump (left ventricular assist device); Procedure: Conventional hemodynamic monitoring

Medical therapy + pulmonary artery catheter

ACTIVE COMPARATOR

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.

Device: Pulmonary artery catheter; Procedure: Hemodynamic stabilization

Medical therapy + conventional monitoring

ACTIVE COMPARATOR

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.

Procedure: Conventional hemodynamic monitoring; Procedure: Hemodynamic stabilization

Interventions

Microaxial flow pump (left ventricular assist device) 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.

Microaxial flow pump + conventional monitoring; Microaxial flow pump + pulmonary artery catheter

Pulmonary artery catheter DEVICE

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.

Medical therapy + pulmonary artery catheter; Microaxial flow pump + pulmonary artery catheter

Conventional hemodynamic monitoring PROCEDURE

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).

Medical therapy + conventional monitoring; Microaxial flow pump + conventional monitoring

Hemodynamic stabilization PROCEDURE

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.

Medical therapy + conventional monitoring; Medical therapy + pulmonary artery catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Leipzig Heart Science gGmbH: lead
• University of Southern Denmark: collaborator
• Boston Scientific Corporation: collaborator
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (1)

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Holger Thiele, Prof. Dr. med.

  Heart Center Leipzig at University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DOUBLE SHOCK Leipzig Heart Science gGmbH

CONTACT

+49 341 865 251542; DOUBLE-SHOCK@leipzig-heart.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): April 1, 2037
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)