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

December 18, 2014 updated by: Maria Grazia Zenti, Universita di Verona

Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • piazzale Stefani1
      • Verona, piazzale Stefani1, Italy, 37126
        • Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Hypercholesterolemia
  • documented CAD
  • chronic LDL-apheresis treatment

Exclusion Criteria:

  • mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • HELP-apheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and at the end of one LDL-apheresis treatment (about 6 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and at the end of one LDL-apheresis treatment (about 6 hours)
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
before and at the end of one LDL-apheresis treatment (about 6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Investigators

  • Study Director: Enzo Bonora, Professor, Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (ESTIMATE)

September 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZentiPTX3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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