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Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock

Study acronym: PRIME-SHOCK
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07817472
Lead Sponsor Chonnam National University Hospital
Conditions
(from sponsor)		 Myocardial Infarction (MI), Cardiogenic Shock, ST-Segment Elevation Myocardial Infarction(STEMI), Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
Related terms Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Shock, Cardiogenic, ST Elevation Myocardial Infarction
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov