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

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ClinicalTrials.gov Identifier: NCT01678521
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hypercholesterolemia Procedure: LDL-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.


Study Design

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease
Study Start Date : September 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. acute change in PTX3 plasma values [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]
    blood samples will be collected before and after a single LDL-apheresis treatment


Secondary Outcome Measures :
  1. acute change in hsCRP [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]
    blood samples will be collected before and after a single LDL-apheresis treatment

  2. acute change in IL6 and IL10 [ Time Frame: before and at the end of one LDL-apheresis treatment (about 6 hours) ]
    blood samples will be collected before and after a single LDL-apheresis treatment


Biospecimen Retention:   Samples Without DNA
serum and plasma

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01678521


Locations
Italy
Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona
Verona, piazzale Stefani1, Italy, 37126
Sponsors and Collaborators
Universita di Verona
Investigators
Study Director: Enzo Bonora, Professor Universita di Verona
More Information

Responsible Party: Maria Grazia Zenti, principal investigator, Universita di Verona
ClinicalTrials.gov Identifier: NCT01678521     History of Changes
Other Study ID Numbers: MZentiPTX3
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

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

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