<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/NCT03825679</url>
  </required_header>
  <id_info>
    <org_study_id>BEJOT 2018</org_study_id>
    <nct_id>NCT03825679</nct_id>
  </id_info>
  <brief_title>Association Between the Composition of the Bacterial Flora of Thrombi and the Etiological Origin of Cerebral Infarction Treated With Thrombectomy</brief_title>
  <acronym>Bacillus</acronym>
  <official_title>Association Between the Composition of the Bacterial Flora of Thrombi and the Etiological Origin of Cerebral Infarctions Treated With Thrombectomy</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>
      Cerebral infarction is a major health problem. The two most common causes are atherosclerosis&#xD;
      (30 to 35%) and cardio-embolic origin (35 to 40%). However, in 25% of cases the cause is&#xD;
      undetermined, known as cryptogenic stroke or stroke of undetermined origin. Paroxysmal Atrial&#xD;
      Fibrillation appears to cause a significant proportion of these cryptogenic cerebral&#xD;
      infarctions. One of the major challenges in the management of cerebral infarctions is the&#xD;
      prevention of recurrence. If the cause is atheromatous, treatment is based on platelet&#xD;
      antiaggregants and the correction of cardiovascular risk factors. If the cause is atrial&#xD;
      fibrillation, the treatment of choice is anticoagulation therapy. Cryptogenic strokes are&#xD;
      managed with antiplatelet therapy. In past studies, the thrombi responsible for cerebral&#xD;
      infarctions have been analyzed anatomopathologically to see if the composition of the thrombi&#xD;
      could help identify the cause of the cerebral infarction. These studies have proved to be&#xD;
      contradictory. The composition of the bacterial flora of cerebral infarct thrombi has not yet&#xD;
      been studied, apart from some limited data on septic emboli. In myocardial infarction, the&#xD;
      cause of which is almost exclusively atheromatous, bacteria of the periodontal flora have&#xD;
      been detected in thrombi of ST-segment elevation infarctions. The causes of cerebral&#xD;
      infarction are multiple. The hypotheses explored in this study are that there are differences&#xD;
      in the composition of the bacterial flora of the thrombus depending on whether the cause is&#xD;
      atheromatous or cardio-embolic and that the study of the composition of the thrombus could be&#xD;
      used to identify the cardio-embolic cause in patients with cryptogenic cerebral infarction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">January 4, 2020</completion_date>
  <primary_completion_date type="Actual">October 4, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bacterial composition of cardio-embolic thrombi</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.</description>
  </primary_outcome>
  <enrollment type="Actual">45</enrollment>
  <condition>Patient With Symptomatic Cerebral Infarction</condition>
  <condition>Patient Who Has Had a Mechanical Thrombectomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized at the Neurovascular Intensive Care Unit at the Dijon University&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person who has given oral consent (or a close relative or legal representative if the&#xD;
             patient is unable to give consent)&#xD;
&#xD;
          -  Patient with a symptomatic cerebral infarction defined according to WHO criteria, who&#xD;
             has had a mechanical thrombectomy and was hospitalized at the Neurovascular Intensive&#xD;
             Care Unit of the Dijon University Hospital.&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person not affiliated to national health insurance&#xD;
&#xD;
          -  Person under legal protection (curatorship, guardianship)&#xD;
&#xD;
          -  Person under court order&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Patient who refuses to participate in the study&#xD;
&#xD;
          -  Patient (or family member) not reachable by telephone during follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>November 24, 2021</last_update_submitted>
  <last_update_submitted_qc>November 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03825679
org study id: BEJOT 2018
nct id: NCT03825679
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cerebral infarction is a major health problem. The two most common causes are atherosclerosis
      (30 to 35%) and cardio-embolic origin (35 to 40%). However, in 25% of cases the cause is
      undetermined, known as cryptogenic stroke or stroke of undetermined origin. Paroxysmal Atrial
      Fibrillation appears to cause a significant proportion of these cryptogenic cerebral
      infarctions. One of the major challenges in the management of cerebral infarctions is the
      prevention of recurrence. If the cause is atheromatous, treatment is based on platelet
      antiaggregants and the correction of cardiovascular risk factors. If the cause is atrial
      fibrillation, the treatment of choice is anticoagulation therapy. Cryptogenic strokes are
      managed with antiplatelet therapy. In past studies, the thrombi responsible for cerebral
      infarctions have been analyzed anatomopathologically to see if the composition of the thrombi
      could help identify the cause of the cerebral infarction. These studies have proved to be
      contradictory. The composition of the bacterial flora of cerebral infarct thrombi has not yet
      been studied, apart from some limited data on septic emboli. In myocardial infarction, the
      cause of which is almost exclusively atheromatous, bacteria of the periodontal flora have
      been detected in thrombi of ST-segment elevation infarctions. The causes of cerebral
      infarction are multiple. The hypotheses explored in this study are that there are differences
      in the composition of the bacterial flora of the thrombus depending on whether the cause is
      atheromatous or cardio-embolic and that the study of the composition of the thrombus could be
      used to identify the cardio-embolic cause in patients with cryptogenic cerebral infarction.
observational model: Cohort
time perspective: Prospective
measure: Bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin
time frame: Through study completion, an average of 2 years
description: Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.
measure: Bacterial composition of cardio-embolic thrombi
time frame: Through study completion, an average of 2 years
description: Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Infarction
mesh term: Infarction