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Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock
Sponsor: Chonnam National University Hospital
Summary
PRIME-SHOCK is a prospective, single-center, open-label, randomized, superiority trial. Eligible participants with AMICS and a clinical decision to use Impella CP will be randomized in a 1:1 ratio before culprit-lesion PCI. The routine pre-PCI group will undergo Impella CP insertion immediately after allocation and before culprit-lesion PCI. The selective post-PCI group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI. If all post-PCI recovery criteria are met, PCI will be concluded without Impella CP.
Official title: Routine PRe-PCI Versus Selective Post-PCI Impella CP Management and Evaluation in Acute Myocardial Infarction-Related Cardiogenic SHOCK
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2026-10-01
Completion Date
2030-07-31
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Routine pre-PCI Impella CP
In the PCI Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.
Selective post-PCI Impella CP
The selective post-PCI Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion. In the selective post-PCI group, immediate mechanical circulatory support will be instituted during PCI if any of the criteria are met. Impella CP is preferred when feasible. VA-ECMO may be initiated during resuscitation when Impella CP cannot be placed promptly or is insufficient. In the selective post-PCI group, successful culprit-lesion revascularization is done without shock progession, PCI will be concluded without Impella CP only when all of the criteria are met.
Locations (1)
Chonnam National University Hospital
Gwangju, South Korea