Testing CRP apheresis to reduce heart damage after a heart attack
Tests a blood-filtering device to remove C-reactive protein in adults with a heart attack.
Plain-language title generated from the registry record
Registry title: CRP Apheresis in STEMI
Key facts
- Where
- Leipzig and Lübeck, GermanySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04939805, who can take part
Where in Germany
- Leipzig Heart CenterLeipzig, GermanyTaking people
- Medical Clinic II - University Heart Center LübeckLübeck, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Innsbruck
- Trial code
- NCT04939805
- Record updated
- 7 October 2026
- Original 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.Read full original descriptionShow less
Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
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.
Inclusion: 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; Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI); CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI; Eligible for primary PCI; Age ≥18 years; Written informed consent.
Exclusion: Prior acute myocardial infarction, coronary artery bypass surgery or PCI; Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan; The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days; Chronic inflammatory disease; Known history of severe hepatic failure; Chronic kidney disease with a creatinine clearance <30ml/min./1.73m²; CRP >15 mg/l at time of hospital admission; Contraindication to CMR; Pre-STEMI life expectancy of <1 year; Participation in another interventional trial; Limited possibility to join the follow-up examinations (e.g. patient lives abroad); Pregnancy.