CRP Apheresis in STEMI

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    202
  • sponsor
    Medical University Innsbruck
Updated on 22 July 2022
stemi
percutaneous coronary intervention
acute myocardial infarction

Summary

Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.

Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.

Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.

Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.

Details
Condition ST Elevation Myocardial Infarction, C-Reactive Protein, Apheresis, Myocardial Injury
Treatment Selective CRP apheresis using the PentraSorb®-CRP system
Clinical Study IdentifierNCT04939805
SponsorMedical University Innsbruck
Last Modified on22 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
Eligible for primary PCI
Age ≥18 years
Written informed consent

Exclusion Criteria

Prior acute myocardial infarction, coronary artery bypass surgery or PCI
Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan
The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days
CRP >15 mg/l at time of hospital admission
Chronic inflammatory disease
Known history of severe hepatic failure
Chronic kidney disease with a creatinine clearance <30ml/min./1.73m²
Contraindication to CMR
Pre-STEMI life expectancy of <1 year
Participation in another interventional trial
Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
Pregnancy
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