| NCT ID | NCT04939805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2021-04-01 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 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: 1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI. 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
Contact & Investigator
Sebastian J Reinstadler, MD, PhD
PRINCIPAL INVESTIGATOR
University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
Frequently Asked Questions
Who can join the NCT04939805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04939805 currently recruiting?
Yes, NCT04939805 is actively recruiting participants. Contact the research team at sebastian.reinstadler@gmail.com for enrollment information.
Where is the NCT04939805 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Salzburg, Austria, Lübeck, Germany and 1 additional location.
Who is sponsoring the NCT04939805 clinical trial?
NCT04939805 is sponsored by Medical University Innsbruck. The principal investigator is Sebastian J Reinstadler, MD, PhD at University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck. The trial plans to enroll 202 participants.