<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/NCT01734356</url>
  </required_header>
  <id_info>
    <org_study_id>BRD/10/11-P</org_study_id>
    <nct_id>NCT01734356</nct_id>
  </id_info>
  <brief_title>Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells</brief_title>
  <acronym>Diag-iPS</acronym>
  <official_title>Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <brief_summary>
    <textblock>
      The recent developments of research on iPS (induced pluripotent stem) cells lead to the&#xD;
      establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with&#xD;
      genetic and cellular characteristics of the donors. These cells represent a biological&#xD;
      material more readily available to identify the pathophysiological mechanisms involved in the&#xD;
      diseases of BrS or ERS patients, which will lead to the identification of genetic markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy</measure>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Inherited Arrhythmias and Valvulopathies</condition>
  <arm_group>
    <arm_group_label>inherited arrhythmias</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>6 patient with inherited arrhythmias</description>
  </arm_group>
  <arm_group>
    <arm_group_label>valvulopathies</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>6 patient with valvulopathies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8 healthy people for these pathologies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skin biopsies</intervention_name>
    <arm_group_label>controle</arm_group_label>
    <arm_group_label>inherited arrhythmias</arm_group_label>
    <arm_group_label>valvulopathies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient with a family history of inherited arrhythmia or valvulopathy&#xD;
&#xD;
          -  Age : 22-60 yo.&#xD;
&#xD;
          -  patient no confine to bed&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Patient affiliated to the French social security&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patient under 22 yo or adults under guardianship&#xD;
&#xD;
          -  Indication against local anesthesia&#xD;
&#xD;
          -  Anticoagulant treatment&#xD;
&#xD;
          -  Absence or positivity of HIV, HBV, HCV serology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent PROBST</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes UH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 6, 2014</last_update_submitted>
  <last_update_submitted_qc>November 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>iPS</keyword>
  <keyword>fibroblast</keyword>
  <keyword>arrhythmias</keyword>
  <keyword>valvulopathies</keyword>
  <keyword>electrophysiology</keyword>
  <keyword>genetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT01734356
org study id: BRD/10/11-P
nct id: NCT01734356
lead sponsor: 
The recent developments of research on iPS (induced pluripotent stem) cells lead to the
      establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with
      genetic and cellular characteristics of the donors. These cells represent a biological
      material more readily available to identify the pathophysiological mechanisms involved in the
      diseases of BrS or ERS patients, which will lead to the identification of genetic markers.
masking: None (Open Label)
measure: Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient
measure: Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy
arm group label: inherited arrhythmias
arm group type: Other
description: 6 patient with inherited arrhythmias
arm group label: valvulopathies
arm group type: Other
description: 6 patient with valvulopathies
arm group label: controle
arm group type: Other
description: 8 healthy people for these pathologies
intervention type: Other
intervention name: Skin biopsies
arm group label: controle
arm group label: inherited arrhythmias
arm group label: valvulopathies
criteria: 
gender: All
minimum age: 22 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vincent PROBST
role: Principal Investigator
affiliation: Nantes UH
facility: 
country: France
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
mesh term: Heart Valve Diseases