NCT04939805Recruiting
CRP Apheresis in STEMI
Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 7 Jun 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 28 Jan 2026
- Lead sponsor
- Medical University Innsbruck
- Diseases
- Coronary artery disease
- NCT number
- NCT04939805
What you commit to
- Study type: Interventional
- Planned participants: 202
- From 1 Apr 2021 to the primary completion date, 28 Jan 2026
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
Other illness
- 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
Lab values
- Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m²
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinic for Cardiology and Nephrology, Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology. Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Not yet recruiting |
| Leipzig Heart Center Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Medical Clinic II - University Heart Center Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.