Clinical Trial

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

Study acronym: DOUBLE-SHOCK
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07762560
Lead Sponsor Leipzig Heart Science gGmbH
Collaborators: University of Southern Denmark, Boston Scientific Corporation, Heart Center Leipzig - University Hospital
Conditions Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute
Enrollment 780 participants
Start Date 2026-10-01
Primary Completion 2030-10 (estimated)
Study Completion 2037-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-13