An interventional study of Selective CRP apheresis using the PentraSorb®-CRP system in ST Elevation Myocardial Infarction, C-Reactive Protein and Apheresis, sponsored by Medical University Innsbruck. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Treatment
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.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 202 is close to the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
Device: 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.
Primary efficacy endpoint
Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI
Time frame: 5 ± 2 days post PCI
Safety endpoint
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) during hospitalization for the index event
Time frame: during hospitalization for the index event
All-cause mortality or hospitalization for heart failure within 12 months after randomization
All-cause mortality or hospitalization for heart failure within 12 months after randomization (endpoint of interest with respect to the two-stage adaptive design)
Time frame: within 12 months after randomization
CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)
CMR endpoints will be assessed at baseline, 4 and 12 months CMR follow-up study and are defined according to the Journal of American College of Cardiology Scientific Expert Consensus document.
Time frame: at baseline, 4 months and 12 months after PCI for STEMI
Hospitalization for heart failure within 12 months after randomization
Time frame: within 12 months after randomization
Cardiovascular mortality at 12 months
Time frame: within 12 months after randomization
CRP concentrations
CRP concentrations during index hospitalization
Time frame: during hospitalization for the index event
Left ventricular thrombus formation
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Biomarker concentrations of myocardial necrosis (enzymatic infarct size; high-sensitivity troponin T)
Time frame: at baseline, 4 months, 12 months post PCI
Biomarker concentrations of hemodynamic stress (N-terminal pro-B-Type Natriuretic Peptide)
Time frame: at baseline, 4 months, 12 months post PCI
Renal function (eGFR)
as measured by the MDRD and CKD-EPI formula
Time frame: during hospitalization for the index event
Renal function (Cystatin C-based calculation of creatinine clearance)
Time frame: during hospitalization for the index event
Cardiac autonomic function: Deceleration capacity of heart rate
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Heart rate variability
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Periodic repolarization dynamics
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Baroreflex sensitivity
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Cardiac autonomic function: Skin sympathetic nerve activity
Time frame: 5 ± 2 days, 4 months, 12 months post PCI
Ran from Apr 2021 to primary completion in Jan 2026, 57 months.
Of 134 non-industry interventional studies with no phase under ST Elevation Myocardial Infarction, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's 57 months is above that.
Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 19 and three quarters within 64.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: primary completion Aug 2025 → Jan 2026 and completion Aug 2025 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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