<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01678521</url>
  </required_header>
  <id_info>
    <org_study_id>MZentiPTX3</org_study_id>
    <nct_id>NCT01678521</nct_id>
  </id_info>
  <brief_title>Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients</brief_title>
  <official_title>Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional&#xD;
      pattern-recognition protein, is expressed in many tissues/cells, including innate immunity&#xD;
      cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert&#xD;
      protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and&#xD;
      future cardiovascular risk.&#xD;
&#xD;
      LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of&#xD;
      coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the&#xD;
      procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on&#xD;
      plasma PTX3 levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypercholesterolemic patients with documented CAD, on chronic fortnightly LDL-apheresis&#xD;
      treatment will be enrolled in this study.&#xD;
&#xD;
      Blood samples will be collected before and after a single LDL-Apheresis treatment to asses&#xD;
      PTX3, HsCRP, IL6, IL10, Fibrinogen and lipid plasma levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>acute change in PTX3 plasma values</measure>
    <time_frame>before and at the end of one LDL-apheresis treatment (about 6 hours)</time_frame>
    <description>blood samples will be collected before and after a single LDL-apheresis treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute change in hsCRP</measure>
    <time_frame>before and at the end of one LDL-apheresis treatment (about 6 hours)</time_frame>
    <description>blood samples will be collected before and after a single LDL-apheresis treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute change in IL6 and IL10</measure>
    <time_frame>before and at the end of one LDL-apheresis treatment (about 6 hours)</time_frame>
    <description>blood samples will be collected before and after a single LDL-apheresis treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Hypercholesterolemic patients</arm_group_label>
    <description>Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LDL-apheresis</intervention_name>
    <description>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.</description>
    <arm_group_label>Hypercholesterolemic patients</arm_group_label>
    <other_name>HELP-apheresis</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis&#xD;
        treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypercholesterolemia&#xD;
&#xD;
          -  documented CAD&#xD;
&#xD;
          -  chronic LDL-apheresis treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enzo Bonora, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Universita di Verona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona</name>
      <address>
        <city>Verona</city>
        <state>piazzale Stefani1</state>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>December 18, 2014</last_update_submitted>
  <last_update_submitted_qc>December 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>Maria Grazia Zenti</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Hypercholesterolemia</keyword>
  <keyword>LDL-apheresis</keyword>
  <keyword>Coronary artery disease</keyword>
  <keyword>PTX3</keyword>
  <keyword>CRP</keyword>
  <keyword>IL6</keyword>
  <keyword>IL10</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678521
org study id: MZentiPTX3
nct id: NCT01678521
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: acute change in PTX3 plasma values
time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)
description: blood samples will be collected before and after a single LDL-apheresis treatment
measure: acute change in hsCRP
time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)
description: blood samples will be collected before and after a single LDL-apheresis treatment
measure: acute change in IL6 and IL10
time frame: before and at the end of one LDL-apheresis treatment (about 6 hours)
description: blood samples will be collected before and after a single LDL-apheresis treatment
arm group label: Hypercholesterolemic patients
description: Hypercholesterolemic Patients with documented CAD and poor- or non responders or intolerant to pharmacological treatment (statins) on chronic LDL-apheresis treatment
intervention type: Procedure
intervention name: LDL-apheresis
description: 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.
arm group label: Hypercholesterolemic patients
other name: HELP-apheresis
serum and plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Enzo Bonora, Professor
role: Study Director
affiliation: Universita di Verona
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: Maria Grazia Zenti
investigator title: principal investigator
mesh term: Hypercholesterolemia