CRP Apheresis in STEMI

NCT04939805 | Recruiting DMC

• 1 other identifier: 20210121-2475
• Study Type: interventional
• Target: 202
• Locations: 2 countries
• Sites: 5

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.

Conditions

ST Elevation Myocardial Infarction; C-Reactive Protein; Apheresis; Myocardial Injury

Keywords

Cardiac magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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

  5 ± 2 days post PCI

Secondary Outcomes (16)

• Safety endpoint

  during hospitalization for the index event

• All-cause mortality or hospitalization for heart failure within 12 months after randomization

  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)

  at baseline, 4 months and 12 months after PCI for STEMI

• Hospitalization for heart failure within 12 months after randomization

  within 12 months after randomization

• Cardiovascular mortality at 12 months

  within 12 months after randomization

Study Arms (2)

Selective CRP apheresis as an adjunct to standard of care

EXPERIMENTAL

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

Standard of care according to current guideline recommendations

NO INTERVENTION

Interventions

Selective CRP apheresis using the PentraSorb®-CRP system DEVICE

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 as an adjunct to standard of care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
• CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
• Eligible for primary PCI
• Age ≥18 years
• Written informed consent

You may not qualify if:

• Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
• Persistent hemodynamic instability (Killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
• The patient is febrile (temperature \>38°C) or has experienced an acute infection with fever in the last 14 days.
• CRP \>15 mg/l at time of hospital admission.
• Chronic inflammatory disease.
• Known history of severe hepatic failure
• Chronic kidney disease with a creatinine clearance \<30ml/min./1.73m²
• Contraindication to CMR.
• Pre-STEMI life expectancy of \<1 year
• Participation in another interventional trial
• Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
• Pregnancy

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (5)

University Clinic for Cardiology and Nephrology, Medical University of Graz

Graz, 8036, Austria

RECRUITING

University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology.

Innsbruck, 6020, Austria

RECRUITING

University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

NOT YET RECRUITING

Medical Clinic II - University Heart Center Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

NOT YET RECRUITING

Leipzig Heart Center

Leipzig, 04289, Germany

RECRUITING

Related Publications (1)

• 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. 2026 Jan;291:1-9. doi: 10.1016/j.ahj.2025.07.067. Epub 2025 Jul 28.

  PMID: 40738310 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Sebastian J Reinstadler, MD, PhD

  University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian J Reinstadler, MD, PhD

CONTACT

+43 (0) 512 504 25665; sebastian.reinstadler@gmail.com

Ivan Lechner, MD, PhD

CONTACT

+43 (0) 512 504 25665; ivan.lechner@tirol-kliniken.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 25, 2021
• Study Start: April 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

DE (2); AU (3)