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CRP Apheresis in STEMI

RecruitingNAAges 18 Years - 85 YearsAllMedical University Innsbruck
NCT04939805 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Desi

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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 2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI) 3. CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI 4. Eligible for primary PCI 5. Age ≥18 years 6. Written informed consent Exclusion Criteria: 1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI. 2. Persistent hemodynamic instability (Killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan. 3. The patient is febrile (temperature \>38°C) or has experienced an acute infection with fever in the last 14 days. 4. CRP \>15 mg/l at time of hospital admission. 5. Chronic inflammatory disease. 6. Known history of severe hepatic failure 7. Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m² 8. Contraindication to CMR. 9. Pre-STEMI life expectancy of \<1 year 10. Participation in another interventional trial 11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad) 12. Pregnancy
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What it tests

  • Selective CRP apheresis using the PentraSorb®-CRP system
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Where

5 sites
University Clinic for Cardiology and Nephrology, Medical University of Graz
Graz, Austria
University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.
Innsbruck, Austria
University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg
Salzburg, Austria
Medical Clinic II - University Heart Center Lübeck
Lübeck, Germany
Leipzig Heart Center
Leipzig, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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