Actively Recruiting
CRP Apheresis in STEMI
Led by Medical University Innsbruck · Updated on 2025-05-09
202
Participants Needed
5
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CRP Apheresis in STEMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of first acute STEMI following European Society of Cardiology guidelines
- Symptoms consistent with STEMI starting more than 30 minutes but less than 12 hours before primary PCI
- C-reactive protein (CRP) level of 7 mg/l or higher measured 6 to 16 hours after primary PCI
- Eligible for primary PCI treatment
- Age 18 years or older
- Provided written informed consent
You will not qualify if you...
- Previous acute myocardial infarction, coronary artery bypass surgery, or PCI
- Persistent hemodynamic instability (Killip class >2) or resuscitated cardiac arrest preventing CMR scan
- Fever over 38°C or acute infection with fever in last 14 days
- CRP level over 15 mg/l at hospital admission
- Chronic inflammatory diseases
- Severe liver failure
- Chronic kidney disease with creatinine clearance below 30 ml/min/1.73m²
- Contraindication to cardiac magnetic resonance (CMR) imaging
- Life expectancy less than 1 year before STEMI
- Participation in another interventional trial
- Limited ability to attend follow-up examinations
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University Clinic for Cardiology and Nephrology, Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
2
University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.
Innsbruck, Austria, 6020
Actively Recruiting
3
University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg
Salzburg, Austria, 5020
Not Yet Recruiting
4
Medical Clinic II - University Heart Center Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Not Yet Recruiting
5
Leipzig Heart Center
Leipzig, Germany, 04289
Actively Recruiting
Research Team
S
Sebastian J Reinstadler, MD, PhD
CONTACT
I
Ivan Lechner, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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