Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
202 participants
INTERVENTIONAL
2021-04-01
2025-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Selective CRP apheresis as an adjunct to standard of care
Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
Selective CRP apheresis using the PentraSorb®-CRP system
Selective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
Standard of care according to current guideline recommendations
No interventions assigned to this group
Interventions
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Selective CRP apheresis using the PentraSorb®-CRP system
Selective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
Eligibility Criteria
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Inclusion Criteria
2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
3. CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
4. Eligible for primary PCI
5. Age ≥18 years
6. Written informed consent
Exclusion Criteria
2. Persistent hemodynamic instability (Killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
3. The patient is febrile (temperature \>38°C) or has experienced an acute infection with fever in the last 14 days.
4. CRP \>15 mg/l at time of hospital admission.
5. Chronic inflammatory disease.
6. Known history of severe hepatic failure
7. Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m²
8. Contraindication to CMR.
9. Pre-STEMI life expectancy of \<1 year
10. Participation in another interventional trial
11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
12. Pregnancy
18 Years
85 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Principal Investigators
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Sebastian J Reinstadler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
Locations
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University Clinic for Cardiology and Nephrology, Medical University of Graz
Graz, , Austria
University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.
Innsbruck, , Austria
University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg
Salzburg, , Austria
Medical Clinic II - University Heart Center Lübeck
Lübeck, Schleswig-Holstein, Germany
Leipzig Heart Center
Leipzig, , Germany
Countries
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Central Contacts
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Facility Contacts
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Heiko Bugger, MD
Role: primary
Lukas J Motloch, MD, PhD
Role: primary
Thomas Stiermaier, MD
Role: primary
Hans-Josef Feistritzer, MD, PhD
Role: primary
References
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Reinstadler SJ, Kronbichler A, Reindl M, Tiller C, Holzknecht M, Oberhollenzer F, Kaser A, Gauckler P, Stiermaier T, Feistritzer HJ, Mayr A, Gizewski ER, Rezar R, Bugger H, Eller K, Eitel I, Schneider S, Mayer G, Thiele H, Bauer A, Metzler B, Lechner I; CRP-STEMI Investigators. Selective C-reactive protein apheresis in ST-elevation myocardial infarction: Design and rationale of the randomized CRP-STEMI trial. Am Heart J. 2025 Jul 28;291:1-9. doi: 10.1016/j.ahj.2025.07.067. Online ahead of print.
Other Identifiers
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20210121-2475
Identifier Type: -
Identifier Source: org_study_id
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