Selective C-reactive Protein Apheresis Using PentraSorb-CRP System to Reduce Heart Damage After ST-Elevation Myocardial Infarction Treated by PCI

What this Trial Is About

Researchers are investigating the effects of selective C-reactive protein CRP apheresis in patients who have experienced an acute ST-elevation myocardial infarction STEMI. The study aims to assess whether reducing CRP levels with the PentraSorb4-CRP system, in addition to standard care, can decrease the size of the heart muscle damage caused by the infarction. This trial is a prospective, randomized, open-label study with masked outcome assessors, designed to provide evidence on the impact of this approach on infarct size and clinical outcomes after primary percutaneous coronary intervention PCI. Participants will be randomly assigned to receive either selective CRP apheresis using the PentraSorb4-CRP system as an add-on to standard treatment or standard care alone. The apheresis procedure will be performed on days 1, 2, and 3 following PCI. This trial compares these two groups to evaluate the effect of CRP removal on heart muscle injury and recovery. During the study, participants will undergo assessments including cardiac magnetic resonance imaging CMR at baseline, 4 months, and 12 months after PCI to measure heart function, infarct size, and other cardiac parameters. Various biomarkers related to myocardial injury, inflammation, and cardiac autonomic function will be monitored during hospitalization and follow-up. Safety and clinical outcomes such as mortality and heart failure-related hospitalizations will be tracked up to 12 months after randomization. The primary outcome is measured approximately 5 days after PCI, with extended follow-up to capture longer-term effects.

CRP Apheresis in STEMI