Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 8 for:    CRP apheresis

CRP Apheresis in STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939805
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

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.


Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction C-Reactive Protein Apheresis Myocardial Injury Device: Selective CRP apheresis using the PentraSorb®-CRP system Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Standard of care according to current guideline recommendations



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939805


Contacts
Layout table for location contacts
Contact: Sebastian J Reinstadler, MD, PhD +43 (0) 512 504 25665 sebastian.reinstadler@gmail.com
Contact: Ivan Lechner, MD +43 (0) 512 504 25665 ivan.lechner@tirol-kliniken.at

Locations
Layout table for location information
Austria
University Clinic for Cardiology and Nephrology, Medical University of Graz Not yet recruiting
Graz, Austria, 8036
Contact: Heiko Bugger, MD         
Principal Investigator: Heiko Bugger, MD         
Sub-Investigator: Kathrin Eller, MD         
University Clinic of Internal Medicine III, Cardiology and Angiology. University Clinic of Internal Medicine IV, Nephrology and Hypertensiology. University Clinic of Radiology. Recruiting
Innsbruck, Austria, 6020
Contact: Sebastian J Reinstadler, MD, PhD       sebastian.reinstadler@gmail.com   
Sub-Investigator: Gert Klug, MD         
Sub-Investigator: Andreas Kronbichler, MD, PhD         
Sub-Investigator: Agnes Mayr, MD         
Sub-Investigator: Martin Reindl, MD, PhD         
Sub-Investigator: Ivan Lechner, MD         
Sub-Investigator: Christina Tiller, MD         
Sub-Investigator: Magdalena Holzknecht, MD         
Sub-Investigator: Philipp Gauckler, MD         
Sub-Investigator: Sara Denicolò, MD         
Sub-Investigator: Bernhard Metzler, MD, MSc         
Sub-Investigator: Axel Bauer, MD         
Sub-Investigator: Gert Mayer, MD         
Sub-Investigator: Elke Gizewski, MD         
University Clinic of Internal Medicine II, Paracelsus Medical University Salzburg Not yet recruiting
Salzburg, Austria, 5020
Contact: Lukas J Motloch, MD, PhD         
Principal Investigator: Lukas J Motloch, MD, PhD         
Germany
Medical Clinic II - University Heart Center Lübeck Not yet recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Thomas Stiermaier, MD         
Principal Investigator: Ingo Eitel, Prof.         
Sub-Investigator: Thomas Stiermaier, MD.         
Leipzig Heart Center Not yet recruiting
Leipzig, Germany, 04289
Contact: Hans-Josef Feistritzer, MD, PhD         
Principal Investigator: Holger Thiele, MD         
Sub-Investigator: Hans-Josef Feistritzer, MD, PhD         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Layout table for investigator information
Principal Investigator: Sebastian J Reinstadler, MD, PhD University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck
Layout table for additonal information
Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04939805    
Other Study ID Numbers: 20210121-2475
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University Innsbruck:
Cardiac magnetic resonance imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases