NCT04939805

CRP Apheresis in STEMI

Recruiting now NA Last updated 9 May 2025

What this trial tests

NA trial testing Selective CRP apheresis using the PentraSorb®-CRP system in ST Elevation Myocardial Infarction in 202 participants. Currently enrolling.

Timeline

1 April 2021

Primary endpoint
31 August 2025

31 August 2025

Quick facts

Lead sponsor	Medical University Innsbruck
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	202
Start date	1 April 2021
Primary completion	31 August 2025
Estimated completion	31 August 2025
Sites	5 locations across Austria, Germany

Drugs / interventions tested

• Selective CRP apheresis using the PentraSorb®-CRP system

Conditions studied

• ST Elevation Myocardial Infarction — all drugs for ST Elevation Myocardial Infarction →
• C-Reactive Protein — all drugs for C-Reactive Protein →
• Apheresis — all drugs for Apheresis →
• Myocardial Injury — all drugs for Myocardial Injury →

Sponsor

Medical University Innsbruck

Who can join

Adults 18 to 85, any sex, with ST Elevation Myocardial Infarction or C-Reactive Protein. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. C-reactive protein: a target for therapy to reduce inflammation.
   Rizo-Téllez SA, Sekheri M, Filep JG. · · 2023 · cited 102× · PMID 37564640 · DOI 10.3389/fimmu.2023.1237729
2. Targeting C-Reactive Protein by Selective Apheresis in Humans: Pros and Cons.
   Torzewski J, Brunner P, Ries W, Garlichs CD, et al · · 2022 · cited 18× · PMID 35407379 · DOI 10.3390/jcm11071771
3. Cardioprotective Strategies After Ischemia-Reperfusion Injury.
   Zhang H, Hu H, Zhai C, Jing L, et al · · 2024 · cited 13× · PMID 37815758 · DOI 10.1007/s40256-023-00614-4
4. Association of C-Reactive Protein Velocity with Early Left Ventricular Dysfunction in Patients with First ST-Elevation Myocardial Infarction.
   Holzknecht M, Tiller C, Reindl M, Lechner I, et al · · 2021 · cited 12× · PMID 34884196 · DOI 10.3390/jcm10235494
5. Temporal Trends in Infarct Severity Outcomes in ST-Segment-Elevation Myocardial Infarction: A Cardiac Magnetic Resonance Imaging Study.
   Lechner I, Reindl M, Tiller C, Holzknecht M, et al · · 2023 · cited 11× · PMID 37489726 · DOI 10.1161/jaha.122.028932
6. Anti-Inflammatory Drug Candidates for Prevention and Treatment of Cardiovascular Diseases.
   Delbaere Q, Chapet N, Huet F, Delmas C, et al · · 2023 · cited 11× · PMID 36678575 · DOI 10.3390/ph16010078
7. Sustainability of C-Reactive Protein Apheresis in Acute Myocardial Infarction-Results from a Supplementary Data Analysis of the Exploratory C-Reactive Protein in Acute Myocardial Infarction-1 Study.
   Skarabis H, Torzewski J, Ries W, Heigl F, et al · · 2022 · cited 4× · PMID 36362673 · DOI 10.3390/jcm11216446
8. [CRP apheresis in acute myocardial infarction and COVID-19].
   Buerke M, Sheriff A, Garlichs CD. · · 2022 · cited 3× · PMID 35333926 · DOI 10.1007/s00063-022-00911-x