<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/NCT04489199</url>
  </required_header>
  <id_info>
    <org_study_id>BEJOT 2020</org_study_id>
    <nct_id>NCT04489199</nct_id>
  </id_info>
  <brief_title>Dijon Stroke Cohort</brief_title>
  <acronym>DISCO</acronym>
  <official_title>Dijon Stroke Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public&#xD;
      Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral&#xD;
      infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic&#xD;
      attacks (TIAs) within the city of Dijon since 1985.&#xD;
&#xD;
      As a result of the development of therapies for acute disease, the prognosis of patients has&#xD;
      improved over time. Thus, the number of stroke survivors has increased by 90% between the&#xD;
      1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and&#xD;
      functional impact of stroke for motor, cognitive or thymic function. In the absence of&#xD;
      available data in France, the investigators wish to set up an extended cohort follow-up of&#xD;
      patients in order to study their long-term prognosis and to study the impact of future&#xD;
      therapies on the evolutionary course of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">January 2040</completion_date>
  <primary_completion_date type="Anticipated">January 2040</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death rate</measure>
    <time_frame>Trough study completion, an average of 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability rate</measure>
    <time_frame>Trough study completion, an average of 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Questionnaire</measure>
    <time_frame>Trough study completion, an average of 10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological questionnaire</measure>
    <time_frame>Trough study completion, an average of 10 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>CVA, Dijon Registry</condition>
  <arm_group>
    <arm_group_label>Stroke patient</arm_group_label>
    <description>Patient included in the Dijon Stroke Registry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire and semi-structured interview</intervention_name>
    <description>questionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes</description>
    <arm_group_label>Stroke patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients included in the Dijon Stroke Registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients included in the Dijon Stroke Registry and not opposed to participating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minor patients; opposition to participation&#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_contact>
    <last_name>Yannick BEJOT</last_name>
    <phone>03.80.29.37.53</phone>
    <phone_ext>+33</phone_ext>
    <email>yannick.bejo@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yannick BEJOT</last_name>
      <phone>03.80.29.37.53</phone>
      <phone_ext>+33</phone_ext>
      <email>yannick.bejo@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04489199
org study id: BEJOT 2020
nct id: NCT04489199
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public
      Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral
      infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic
      attacks (TIAs) within the city of Dijon since 1985.

      As a result of the development of therapies for acute disease, the prognosis of patients has
      improved over time. Thus, the number of stroke survivors has increased by 90% between the
      1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and
      functional impact of stroke for motor, cognitive or thymic function. In the absence of
      available data in France, the investigators wish to set up an extended cohort follow-up of
      patients in order to study their long-term prognosis and to study the impact of future
      therapies on the evolutionary course of the disease.
observational model: Cohort
time perspective: Prospective
measure: Death rate
time frame: Trough study completion, an average of 10 years
measure: Disability rate
time frame: Trough study completion, an average of 10 years
measure: Quality of Life Questionnaire
time frame: Trough study completion, an average of 10 years
measure: Neuropsychological questionnaire
time frame: Trough study completion, an average of 10 years
arm group label: Stroke patient
description: Patient included in the Dijon Stroke Registry.
intervention type: Other
intervention name: Questionnaire and semi-structured interview
description: questionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes
arm group label: Stroke patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yannick BEJOT
phone: 03.80.29.37.53
phone ext: +33
email: yannick.bejo@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor