<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/NCT03787277</url>
  </required_header>
  <id_info>
    <org_study_id>7310</org_study_id>
    <nct_id>NCT03787277</nct_id>
  </id_info>
  <brief_title>CT Evaluation of Intimal Flap Mobility</brief_title>
  <acronym>CT-MOBILITY</acronym>
  <official_title>CT Evaluation of Intimal Flap Mobility as a Potential Predictor of Residual Type B Dissection Evolution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Type A aortic dissection is an emergency condition, defined by the appearance of an intimal&#xD;
      flap within the ascending aorta. Urgent treatment is required, with surgical replacement of -&#xD;
      at minima - the tubular portion of the ascending aorta.&#xD;
&#xD;
      After surgery, a majority of patients will still have a residual aortic dissection involving&#xD;
      the aortic arch and/or the descending aorta. Long-term survival in these patients can be&#xD;
      hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of&#xD;
      rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up&#xD;
      imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the&#xD;
      extension of the dissection and the diameters of the dissected aorta. Patient management is&#xD;
      therefore based on passive follow-up of the disease, as no definitive clinical or imaging&#xD;
      features can predict the potential evolution (or the absence of) towards an aneurysmal&#xD;
      evolution.&#xD;
&#xD;
      Therefore, one can understand the important need for accurate predictors of aneurysmal&#xD;
      dilatation of post-operative residual dissection.&#xD;
&#xD;
      CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4&#xD;
      cardiac cycles over a non-gated arterial acquisition.&#xD;
&#xD;
      This intimal flap mobility varies greatly between patients, between the localization and the&#xD;
      extension of the dissection, and between acute and chronic dissections. It is thought that&#xD;
      chronic dissections with immobile flap might be less prone to aneurysmal evolution.&#xD;
&#xD;
      The investigators hypothesize that this mobility could be a prognostic marker for the&#xD;
      evolution towards aortic dilatation: flap that would remain highly mobile after initial&#xD;
      surgery could be an additional marker towards an aneurysmal evolution, while immobile flap&#xD;
      could be on the contrary a marker of stability.&#xD;
&#xD;
      Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when&#xD;
      ECG-synchronization is used. However, this technique has a limited availability and&#xD;
      significantly increases the total radiation dose, therefore limiting its use in routine&#xD;
      practice. Being able to quantify this marker using routine non ECG-gated CTA could be a&#xD;
      significant addition to the literature, as it is currently unknown if this is&#xD;
      feasible/relevant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the mobility of the intimal flap with CT angiography without the use of ECG synchronization</measure>
    <time_frame>The period from January 1st, 2010 to December 31, 2015 will be examined</time_frame>
    <description>The study concerns patients operated at Strasbourg University Hospitals for the replacement of the ascending aorta for aortic dissection from 2010 to 2015</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Aortic Dissection Type A</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient having ascending aorta replacement for aortic dissection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Major patient (≥18 years old)&#xD;
&#xD;
          -  Ascending aorta replacement for aortic dissection, between 2010 and 2015 (timeframe&#xD;
             established to allow for a significant follow-up period after surgery)&#xD;
&#xD;
          -  Residual type B dissection after surgery availability of thin-slices good quality CT&#xD;
             angiography before (at least one) and after (at least two) the surgery.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient expressing opposition to participating in the study&#xD;
&#xD;
          -  Patient under the protection of justice&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Mickaël OHANA, MD</last_name>
    <phone>33 3 69 55 11 17</phone>
    <email>mickael.ohana@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joseph ATLAN, MD</last_name>
    <phone>33 3 69 55 10 83</phone>
    <email>joseph.atlan@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de Radiologie B - NHC</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mickaël OHANA, MD</last_name>
      <phone>33 3 69 55 11 17</phone>
      <email>mickael.ohana@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Joseph ATLAN, MD</last_name>
      <phone>33 3 69 5510 83</phone>
      <email>joseph.atlan@chru-strasbourg.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Mickaël OHANA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph ATLAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic Dissection Type A</keyword>
  <keyword>Post operative residual aortic dissection</keyword>
  <keyword>Aneurysmal progression of the dissected aorta</keyword>
  <keyword>Intimal flap mobility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT03787277
org study id: 7310
nct id: NCT03787277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type A aortic dissection is an emergency condition, defined by the appearance of an intimal
      flap within the ascending aorta. Urgent treatment is required, with surgical replacement of -
      at minima - the tubular portion of the ascending aorta.

      After surgery, a majority of patients will still have a residual aortic dissection involving
      the aortic arch and/or the descending aorta. Long-term survival in these patients can be
      hindered by the apparition of an aneurysmal progression of the dissected aorta, with risk of
      rupture, thrombose and/or embolism. Consequently, this condition requires frequent follow-up
      imaging examinations, usually by Computed Tomography Angiography (CTA), to monitor the
      extension of the dissection and the diameters of the dissected aorta. Patient management is
      therefore based on passive follow-up of the disease, as no definitive clinical or imaging
      features can predict the potential evolution (or the absence of) towards an aneurysmal
      evolution.

      Therefore, one can understand the important need for accurate predictors of aneurysmal
      dilatation of post-operative residual dissection.

      CTA has the ability to visualize the intimal flap motion, by averaging at least 3 or 4
      cardiac cycles over a non-gated arterial acquisition.

      This intimal flap mobility varies greatly between patients, between the localization and the
      extension of the dissection, and between acute and chronic dissections. It is thought that
      chronic dissections with immobile flap might be less prone to aneurysmal evolution.

      The investigators hypothesize that this mobility could be a prognostic marker for the
      evolution towards aortic dilatation: flap that would remain highly mobile after initial
      surgery could be an additional marker towards an aneurysmal evolution, while immobile flap
      could be on the contrary a marker of stability.

      Intimal flap motion can already be qualitatively and quantitatively assessed in CTA when
      ECG-synchronization is used. However, this technique has a limited availability and
      significantly increases the total radiation dose, therefore limiting its use in routine
      practice. Being able to quantify this marker using routine non ECG-gated CTA could be a
      significant addition to the literature, as it is currently unknown if this is
      feasible/relevant.
observational model: Case-Only
time perspective: Retrospective
measure: Evaluate the mobility of the intimal flap with CT angiography without the use of ECG synchronization
time frame: The period from January 1st, 2010 to December 31, 2015 will be examined
description: The study concerns patients operated at Strasbourg University Hospitals for the replacement of the ascending aorta for aortic dissection from 2010 to 2015
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Mickaël OHANA, MD
phone: 33 3 69 55 11 17
email: mickael.ohana@chru-strasbourg.fr
last name: Joseph ATLAN, MD
phone: 33 3 69 55 10 83
email: joseph.atlan@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Aortic Dissection