CRP Apheresis in STEMI

Last updated: May 6, 2025
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Coronary Artery Disease

Cardiovascular Disease

Treatment

Selective CRP apheresis using the PentraSorb®-CRP system

Clinical Study ID

NCT04939805
20210121-2475
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 patientspresenting 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

Exclusion Criteria:

  1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI.

  2. Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) orresuscitated cardiac arrest not allowing a CMR scan.

  3. The patient is febrile (temperature >38°C) or has experienced an acute infectionwith 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

Study Design

Total Participants: 202
Treatment Group(s): 1
Primary Treatment: Selective CRP apheresis using the PentraSorb®-CRP system
Phase:
Study Start date:
April 01, 2021
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • University Clinic for Cardiology and Nephrology, Medical University of Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Medical Clinic II - University Heart Center Lübeck

    Lübeck, Schleswig-Holstein 23538
    Germany

    Site Not Available

  • Leipzig Heart Center

    Leipzig, 04289
    Germany

    Active - Recruiting

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