Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial.
Sebastian J Reinstadler, Andreas Kronbichler, Martin Reindl...
https://pubmed.ncbi.nlm.nih.gov/40738310Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04939805
Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
Led by Medical University Innsbruck · Updated on 2025-05-09
202
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of selective C-reactive protein (CRP) apheresis in patients who have experienced an acute ST-elevation myocardial infarction (STEMI). The study aims to assess whether reducing CRP levels with the PentraSorb4-CRP system, in addition to standard care, can decrease the size of the heart muscle damage caused by the infarction. This trial is a prospective, randomized, open-label study with masked outcome assessors, designed to provide evidence on the impact of this approach on infarct size and clinical outcomes after primary percutaneous coronary intervention (PCI). Participants will be randomly assigned to receive either selective CRP apheresis using the PentraSorb4-CRP system as an add-on to standard treatment or standard care alone. The apheresis procedure will be performed on days 1, 2, and 3 following PCI. This trial compares these two groups to evaluate the effect of CRP removal on heart muscle injury and recovery. During the study, participants will undergo assessments including cardiac magnetic resonance imaging (CMR) at baseline, 4 months, and 12 months after PCI to measure heart function, infarct size, and other cardiac parameters. Various biomarkers related to myocardial injury, inflammation, and cardiac autonomic function will be monitored during hospitalization and follow-up. Safety and clinical outcomes such as mortality and heart failure-related hospitalizations will be tracked up to 12 months after randomization. The primary outcome is measured approximately 5 days after PCI, with extended follow-up to capture longer-term effects.
CONDITIONS
Brief Title
CRP Apheresis in STEMI
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of first acute STEMI according to ESC Guidelines
- Symptoms consistent with STEMI starting more than 30 minutes but less than 12 hours before primary PCI
- CRP elevation of 7 mg/l or higher measured between 6 to 16 hours after primary PCI
- Eligible for primary PCI
- Age 18 years or older
- Written informed consent given
You will not qualify if you...
- Previous acute myocardial infarction, coronary artery bypass surgery, or PCI
- Persistent hemodynamic instability (Killip class >2) including cardiogenic shock or resuscitated cardiac arrest preventing CMR scan
- Fever (temperature >38 0C) or acute infection with fever within last 14 days
- CRP greater than 15 mg/l at hospital admission
- Chronic inflammatory disease
- Severe hepatic failure
- Chronic kidney disease with creatinine clearance less than 30 ml/min/1.73m8
- Contraindication to cardiac magnetic resonance imaging (CMR)
- Life expectancy less than 1 year before STEMI
- Participation in another interventional trial
- Limited ability to attend follow-up examinations (e.g., living abroad)
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 3 days
Participants receive selective CRP apheresis using the PentraSorb®-CRP system as an adjunct to standard care. Apheresis is performed on day 1, 2, and 3 after PCI.
3 visits (in-person on days 1, 2, and 3 post PCI)
Long-term Monitoring
Duration - 12 months
Participants are monitored for safety and efficacy outcomes including heart function, biomarker levels, and clinical events up to 12 months after randomization.
Visits at baseline, 5 ± 2 days, 4 months, and 12 months post PCI
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
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Research Team
S
Sebastian J Reinstadler, MD, PhD
I
Ivan Lechner, MD, PhD
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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