<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/NCT04408404</url>
  </required_header>
  <id_info>
    <org_study_id>CCVT- Dissection</org_study_id>
    <nct_id>NCT04408404</nct_id>
  </id_info>
  <brief_title>Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital</brief_title>
  <official_title>Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier La Chartreuse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic.&#xD;
      Global mortality remains high even if it decreased last years. This is probably due to&#xD;
      improvement of diagnostic techniques and the evolution of surgical practices. It is however&#xD;
      important to have medical data and statistics obtained in past years in order to better&#xD;
      understand the factors influencing peroperative mortality and thereby to continue this&#xD;
      improvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Monitor peri-operative mortality incidence rates</measure>
    <time_frame>1 day</time_frame>
    <description>Mortality during peri-operative acute aortic dissection procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Monitor peri-operative morbidity incidence rates</measure>
    <time_frame>1 day</time_frame>
    <description>Stroke, Kidney failure, Reexploration for bleeding</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">230</enrollment>
  <condition>Aortic Dissection</condition>
  <arm_group>
    <arm_group_label>Type A aortic dissection</arm_group_label>
    <description>Patient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acute aortic dissection</intervention_name>
    <description>Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)</description>
    <arm_group_label>Type A aortic dissection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital&#xD;
        since the 01 January 2007 and the 31 december 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who died before the surgical incision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiovascular and thoracic surgery Unit - Dijon University Hopital</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</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>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.</ipd_description>
  </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/NCT04408404
org study id: CCVT- Dissection
nct id: NCT04408404
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic.
      Global mortality remains high even if it decreased last years. This is probably due to
      improvement of diagnostic techniques and the evolution of surgical practices. It is however
      important to have medical data and statistics obtained in past years in order to better
      understand the factors influencing peroperative mortality and thereby to continue this
      improvement.
observational model: Cohort
time perspective: Retrospective
measure: Monitor peri-operative mortality incidence rates
time frame: 1 day
description: Mortality during peri-operative acute aortic dissection procedure
measure: Monitor peri-operative morbidity incidence rates
time frame: 1 day
description: Stroke, Kidney failure, Reexploration for bleeding
arm group label: Type A aortic dissection
description: Patient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital
intervention type: Procedure
intervention name: Acute aortic dissection
description: Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)
arm group label: Type A aortic dissection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier La Chartreuse
investigator full name: MORGANT Marie-Catherine
investigator title: Principal investigator
mesh term: Aortic Dissection
sharing ipd: No
ipd description: All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.