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CRP Apheresis in Infarct-Related Cardiogenic Shock

RecruitingNAAges 18 Years - 80 YearsAllLeipzig Heart Science gGmbH
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In plain words

What the trial is, and whether it could suit you

Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction. The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system. The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI). * Cardiogenic shock defined as: * Systolic blood pressure \<90 mmHg for \>30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and * Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output \<30 mL/hour, Arterial lactate \>2 mmol/L * C-reactive protein (CRP) level ≥7 mg/L at baseline. * Age ≥18 years. * Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible. Exclusion Criteria: * Fever (body temperature \>38°C) or acute infection with fever within the last 14 days. * Chronic inflammatory disease. * Known history of severe hepatic failure. * Chronic kidney disease with creatinine clearance \<30 mL/min/1.73 m² prior to hospital admission. * Life expectancy \<12 months prior to cardiogenic shock. * Participation in another interventional clinical trial. * Pregnancy. * Resuscitation duration \>30 minutes. * Cardiogenic shock due to causes other than acute myocardial infarction. * Onset of cardiogenic shock \>12 hours before randomization. * Age \>80 years.
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What it tests

  • Selective C-reactive protein apheresis (PentraSorb®-CRP)
  • Standard of care
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Where

1 site
Heart Center Leipzig at University of Leipzig
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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