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Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients

This study is currently recruiting participants.
Verified September 2012 by Universita di Verona
Sponsor:
Information provided by (Responsible Party):
Maria Grazia Zenti, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01678521
First received: August 24, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional pattern-recognition protein, is expressed in many tissues/cells, including innate immunity cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and future cardiovascular risk.

LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on plasma PTX3 levels.


Condition Intervention
Hypercholesterolemia
 Procedure: LDL-apheresis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • acute change in PTX3 plasma values [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ] [ Designated as safety issue: No ]
    blood samples will be collected before and after a single LDL-apheresis treatment


Secondary Outcome Measures:
  • acute change in hsCRP [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ] [ Designated as safety issue: No ]
    blood samples will be collected before and after a single LDL-apheresis treatment

  • acute change in IL6 and IL10 [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ] [ Designated as safety issue: No ]
    blood samples will be collected before and after a single LDL-apheresis treatment


Biospecimen Retention:   Samples Without DNA

serum and plasma


Estimated Enrollment: 12
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypercholesterolemic patients
Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment
 Procedure: LDL-apheresis
The acronym H.E.L.P. stands for Heparin-induced Extracorporeal Low-density-lipoprotein Precipitation. Antecubital veins served as blood access. The mean blood volume processed per session is of approximately 3000 ml.
Other Name: HELP-apheresis

Detailed Description:

Hypercholesterolemic patients with documented CAD, on chronic fortnightly LDL-apheresis treatment will be enrolled in this study.

Blood samples will be collected before and after a single LDL-Apheresis treatment to asses PTX3, HsCRP, IL6, IL10, Fibrinogen and lipid plasma levels.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis treatment.

Criteria

Inclusion Criteria:

  • Hypercholesterolemia
  • documented CAD
  • chronic LDL-apheresis treatment

Exclusion Criteria:

  • mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678521

Contacts
Contact: Maria Grazia Zenti, MD +390458123110 mariagrazia.zenti@univr.it
Contact: Riccardo C Bonadonna, MD, PHD +390458123115 riccardo.bonadonna@univr.it

Locations
Italy
Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona Recruiting
Verona, piazzale Stefani1, Italy, 37126
Contact: Maria Grazia Zenti, MD     +390458123110     mariagrazia.zenti@univr.it    
Contact: Riccardo C Bonadonna, MD,PHD     +390458123115     riccardo.bonadonna@univr.it    
Principal Investigator: Maria Grazia Zenti, MD            
Sponsors and Collaborators
Universita di Verona
Investigators
Study Director: Enzo Bonora, Professor Universita di Verona
  More Information

No publications provided

Responsible Party: Maria Grazia Zenti, principal investigator, Universita di Verona
ClinicalTrials.gov Identifier: NCT01678521     History of Changes
Other Study ID Numbers: MZentiPTX3
Study First Received: August 24, 2012
Last Updated: September 7, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
Hypercholesterolemia
LDL-apheresis
Coronary artery disease
PTX3
 CRP
IL6
IL10

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013