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NCT Number: NCT04939805

CRP Apheresis in STEMI

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.

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Key information

Conditions

ST Elevation Myocardial Infarction Apheresis C-reactive Protein Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Injury Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic for Cardiology and Nephrology, Medical University of Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: 5 ± 2 days post PCI

    Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI

Secondary outcomes

  1. Safety endpoint

    Time frame: during hospitalization for the index event

    Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) during hospitalization for the index event

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

    Time frame: 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)

  3. CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)

    Time frame: at baseline, 4 months and 12 months after PCI for STEMI

    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.

  4. Hospitalization for heart failure within 12 months after randomization

    Time frame: within 12 months after randomization

  5. Cardiovascular mortality at 12 months

    Time frame: within 12 months after randomization

  6. CRP concentrations

    Time frame: during hospitalization for the index event

    CRP concentrations during index hospitalization

  7. Left ventricular thrombus formation

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

  8. Biomarker concentrations of myocardial necrosis (enzymatic infarct size; high-sensitivity troponin T)

    Time frame: at baseline, 4 months, 12 months post PCI

  9. Biomarker concentrations of hemodynamic stress (N-terminal pro-B-Type Natriuretic Peptide)

    Time frame: at baseline, 4 months, 12 months post PCI

  10. Renal function (eGFR)

    Time frame: during hospitalization for the index event

    as measured by the MDRD and CKD-EPI formula

  11. Renal function (Cystatin C-based calculation of creatinine clearance)

    Time frame: during hospitalization for the index event

  12. Cardiac autonomic function: Deceleration capacity of heart rate

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

  13. Cardiac autonomic function: Heart rate variability

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

  14. Cardiac autonomic function: Periodic repolarization dynamics

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

  15. Cardiac autonomic function: Baroreflex sensitivity

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

  16. Cardiac autonomic function: Skin sympathetic nerve activity

    Time frame: 5 ± 2 days, 4 months, 12 months post PCI

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Lechner, MD, PhD

CONTACT

[email protected]

+43 (0) 512 504 25665

Sebastian J Reinstadler, MD, PhD

CONTACT

[email protected]

+43 (0) 512 504 25665

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2021
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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