<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/NCT01731080</url>
  </required_header>
  <id_info>
    <org_study_id>AOI-2011</org_study_id>
    <nct_id>NCT01731080</nct_id>
  </id_info>
  <brief_title>Arterial Wall Calcium Load in Pseudoxanthoma Elasticum</brief_title>
  <acronym>Ca-Art-PXE2</acronym>
  <official_title>Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quantification and preferential sites of arterial wall calcification within the coronary and&#xD;
      lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2&#xD;
      diabetics and Chronic Kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a previous work we have observed that patients suffering from PXE, a soft-tissue&#xD;
      calcifying inherited autosomal disease, exhibited specific structural and functionnal&#xD;
      features within the peripheral arteries. We now want to quantify and determine the&#xD;
      preferential sites of the arterial wall calcification (Agatston score) between these patients&#xD;
      compared to diabetics and patients with chronic renal insufficiency with mediacalcosis.&#xD;
&#xD;
      All variables will be collected from a cohort of PXE monitored in our PXE Health and Care&#xD;
      centre at the university hospital of Angers. Quantification of the arterial wall calcium load&#xD;
      will be performed using helicoidal CT-scan. These variables will be compared to the same&#xD;
      measurements performed in type 2 diabetic and chronic kidney disease patients paired by age&#xD;
      and gender.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>calcification score</measure>
    <time_frame>after inclusion</time_frame>
    <description>the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>site of calcification</measure>
    <time_frame>after inclusion</time_frame>
    <description>the anatomical site of arterial wall calcification determined by a Ct-scan and computed by the Agatston score</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pseudoxanthoma Elasticum</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Pseudoxanthoma Elasticum</arm_group_label>
    <description>Patients with genetically and clincally proven PXE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chronic kidney disease</arm_group_label>
    <description>Type 2 diabetic patients with mediacalcosis and matched to PXE patients for gender and age (+/- 5 yrs).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetes</arm_group_label>
    <description>patients with chronic kidney disease and matched to PXE patients for gender and age (+/- 5 yrs).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pseudoxanthoma Elasticum (PXE)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with phenotypically and genotypically-proven PXE&#xD;
&#xD;
          -  Type 2 diabetic patients with mediacalcosis (i.e. Ankle Brachial Index &gt; 1.30)&#xD;
&#xD;
          -  Patients with a chronic kidney disease (CKD), before kidney transplantation&#xD;
&#xD;
          -  All patients should be affiliated to a Health care system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with unproved PXE&#xD;
&#xD;
          -  Patient under the age of 18 yrs&#xD;
&#xD;
          -  Patient unwilling to participate to the study&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient not affiliated to a Health care system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yannick LE CORRE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, University Hospital of Angers, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yannick LE CORRE, MD</last_name>
    <phone>33(2)41.35.39.10</phone>
    <email>yalecorre@chu-angers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ludovic MARTIN, MD, PhD</last_name>
    <phone>33(2)41.35.34.19</phone>
    <email>lumartin@chu-angers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Angers</city>
        <state>Pays de la Loire</state>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludovic MARTIN, MD, PhD</last_name>
      <phone>33(2)41.35.34.19</phone>
      <email>lumartin@chu-angers.fr</email>
    </contact>
    <contact_backup>
      <last_name>Georges LEFTHERIOTIS, MD, PhD</last_name>
      <phone>33(2)41.35.44.56</phone>
      <email>geleftheriotis@chu-angers.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Yannick LE CORRE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ludovic MARTIN, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Georges LEFTHERIOTIS, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre ABRAHAM, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Serge WILLOTEAUX, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Francois SUBRA, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre-Henri DUCLUZEAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Pseudoxanthoma Elasticum</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01731080
org study id: AOI-2011
nct id: NCT01731080
lead sponsor: 
has dmc: Yes
Quantification and preferential sites of arterial wall calcification within the coronary and
      lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2
      diabetics and Chronic Kidney disease.
In a previous work we have observed that patients suffering from PXE, a soft-tissue
      calcifying inherited autosomal disease, exhibited specific structural and functionnal
      features within the peripheral arteries. We now want to quantify and determine the
      preferential sites of the arterial wall calcification (Agatston score) between these patients
      compared to diabetics and patients with chronic renal insufficiency with mediacalcosis.

      All variables will be collected from a cohort of PXE monitored in our PXE Health and Care
      centre at the university hospital of Angers. Quantification of the arterial wall calcium load
      will be performed using helicoidal CT-scan. These variables will be compared to the same
      measurements performed in type 2 diabetic and chronic kidney disease patients paired by age
      and gender.
observational model: Case-Control
time perspective: Prospective
measure: calcification score
time frame: after inclusion
description: the level of arterial wall calcification determined by a Ct-scan and computed by the Agatston score
measure: site of calcification
time frame: after inclusion
description: the anatomical site of arterial wall calcification determined by a Ct-scan and computed by the Agatston score
arm group label: Pseudoxanthoma Elasticum
description: Patients with genetically and clincally proven PXE
arm group label: chronic kidney disease
description: Type 2 diabetic patients with mediacalcosis and matched to PXE patients for gender and age (+/- 5 yrs).
arm group label: Diabetes
description: patients with chronic kidney disease and matched to PXE patients for gender and age (+/- 5 yrs).
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yannick LE CORRE, MD
role: Principal Investigator
affiliation: Department of Dermatology, University Hospital of Angers, France
last name: Yannick LE CORRE, MD
phone: 33(2)41.35.39.10
email: yalecorre@chu-angers.fr
last name: Ludovic MARTIN, MD, PhD
phone: 33(2)41.35.34.19
email: lumartin@chu-angers.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Pseudoxanthoma Elasticum
mesh term: Diabetes Mellitus, Type 2