<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/NCT03817008</url>
  </required_header>
  <id_info>
    <org_study_id>MORGANT 2019</org_study_id>
    <nct_id>NCT03817008</nct_id>
  </id_info>
  <brief_title>Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement</brief_title>
  <official_title>Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier La Chartreuse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JAZAYERI Aline</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BOUCHOT Olivier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>JAZAYERI Saed</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MALAPERT Ghislain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PETROSYAN Andreanik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier La Chartreuse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study was to evaluate the impact of aortic root replacement by a graft on the&#xD;
      elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging&#xD;
      (MRI) and automatic post-processing.&#xD;
&#xD;
      Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic&#xD;
      compliance measurement was performed before and after surgery. Images were acquired with a&#xD;
      1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational and retrospective trial on medical data only. The patients are operated of&#xD;
      planned aortic root aneurysm without additional intervention.&#xD;
&#xD;
      The pre and postoperative cardiac MRI are planned in standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">January 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Aortic compliance of descending aorta (mm2/mmHg)</measure>
    <time_frame>post-operative cardiac MRI performing between 12 and 24 months</time_frame>
    <description>Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI.&#xD;
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aortic compliance of ascending aorta (mm2/mmHg)</measure>
    <time_frame>post-operative cardiac MRI performing between 12 and 24 months</time_frame>
    <description>Aortic elastic properties of the ascending aorta before and after aortic root replacement using cardiac MRI.&#xD;
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.</description>
  </secondary_outcome>
  <enrollment type="Actual">19</enrollment>
  <condition>Aortic Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ascending aorta replacement with graft</intervention_name>
    <description>Patient with planned Ascending aorta replacement with graft</description>
    <other_name>cardiac MRI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and&#xD;
        December 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  Elective patient&#xD;
&#xD;
          -  Ascending aorta replacement with graft&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior cardiac surgery&#xD;
&#xD;
          -  Contraindication to performing cardiac MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier La Chartreuse</investigator_affiliation>
    <investigator_full_name>MORGANT Marie-Catherine</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03817008
org study id: MORGANT 2019
nct id: NCT03817008
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of our study was to evaluate the impact of aortic root replacement by a graft on the
      elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging
      (MRI) and automatic post-processing.

      Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic
      compliance measurement was performed before and after surgery. Images were acquired with a
      1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.
Observational and retrospective trial on medical data only. The patients are operated of
      planned aortic root aneurysm without additional intervention.

      The pre and postoperative cardiac MRI are planned in standard of care.
observational model: Cohort
time perspective: Retrospective
measure: Aortic compliance of descending aorta (mm2/mmHg)
time frame: post-operative cardiac MRI performing between 12 and 24 months
description: Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI.
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.
measure: Aortic compliance of ascending aorta (mm2/mmHg)
time frame: post-operative cardiac MRI performing between 12 and 24 months
description: Aortic elastic properties of the ascending aorta before and after aortic root replacement using cardiac MRI.
Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing.
intervention type: Procedure
intervention name: Ascending aorta replacement with graft
description: Patient with planned Ascending aorta replacement with graft
other name: cardiac MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier La Chartreuse
investigator full name: MORGANT Marie-Catherine
investigator title: PI
sharing ipd: No