Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07687017

CRP Apheresis in Infarct-Related Cardiogenic Shock

Conditions: Cardiogenic Shock, Acute Myocardial Infarction (AMI)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Leipzig Heart Science gGmbH

Location: Heart Center Leipzig at University of Leipzig Leipzig Saxony

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI). * Cardiogenic shock defined as: * Systolic blood pressure \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 \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 \12 hours before randomization. * Age \>80 years.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07687017). StuddyBuddy aggregates publicly available trial information.