<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/NCT04431609</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2018/40</org_study_id>
    <nct_id>NCT04431609</nct_id>
  </id_info>
  <brief_title>Carotid Web Associated With Cerebral Infarctions</brief_title>
  <acronym>CAROWEB</acronym>
  <official_title>French Cohort of Carotid Web Associated With Cerebral Infarctions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      Carotid Web located at the bulb level is a rare condition and is often associated with severe&#xD;
      cerebral infarction in the carotid territory. This condition has been described predominantly&#xD;
      in the black population. However, limited data are available for the epidemiology of carotid&#xD;
      web and often result from selected population studies. It has been shown that the carotid web&#xD;
      is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients&#xD;
      treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed&#xD;
      including in stroke unit. We assume that the implementation of a multicentric cohort would&#xD;
      allow a comprehensive analysis of the carotid web condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carotid web lesions associated with cerebral infarctions are a relatively rare and largely&#xD;
      unknown disease. However, carotid web lesions are associated with severe infarction involving&#xD;
      the functional and vital prognosis of patients. The high rate of recurrence should lead to an&#xD;
      identification of the lesion at the first event in order to propose a suitable preventive&#xD;
      treatment. We believe that only a multicenter cohort will be able to analyze the&#xD;
      characteristics of the pathology and propose studies on critical size samples. A national&#xD;
      cohort would lead quickly to a consequent collection of cases. By including overseas&#xD;
      departments and communities, notions of prevalence and characteristics within different&#xD;
      populations could finally be studied. Participation to the cohort constitution will probably&#xD;
      lead to sensitizing the various actors of the course of stroke care to the diagnosis and&#xD;
      appropriate care of the carotid web.&#xD;
&#xD;
      Patients will be selected by the Stroke Units which take part in the cohort constitution.&#xD;
      Stroke Unit investigator will fill the WEPI online entry database. Clinical, imaging and&#xD;
      outcome characteristics will be informed.&#xD;
&#xD;
      In order to guarantee the quality of the cases collected, the validation of the carotid web&#xD;
      lesion will be carried out by a pair of expert Neurologist - Neuroradiologist appointed&#xD;
      within an expert committee. In case of no consensus, a third expert will resolve the&#xD;
      disagreement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2019</start_date>
  <completion_date type="Anticipated">June 19, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 19, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Number of patients included and validated by the expert committee at the end of the inclusion period</measure>
    <time_frame>At 3 years</time_frame>
    <description>The missing data concerning clinical data, therapy used and functional prognosis between 3 and 6 months should be &lt;10%. Each item entered in the eCRF can be answered. The lack of response will be considered as missing data in the patient's file.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographics collected at the inclusion</measure>
    <time_frame>at the inclusion</time_frame>
    <description>Age, Sex, Ethnic group based on self-determination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score at the admission in the neurological unit</measure>
    <time_frame>at the inclusion</time_frame>
    <description>NIHSS scale (National Institute of Health Stroke Score) was described by T. Brott, in 1989, for used to assess patients with acute ischemic stroke. It can be used in carotid and vertebrobasilar ischemic attacks. The passing time of the scale is 6 minutes 30 on average. The NIHSS Score ranges from 0 to 42. A higher score indicates a worse clinical status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological of the cerebral infarction collected at the inclusion</measure>
    <time_frame>Web measurements carried out by 2 experts one month after the inclusion</time_frame>
    <description>localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological of the cerebral infarction collected one month after the inclusion</measure>
    <time_frame>Web measurements carried out by 2 experts one month after the inclusion</time_frame>
    <description>localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment</measure>
    <time_frame>at the inclusion</time_frame>
    <description>Number of patients treated with: 1) Thrombolysis, 2) Mechanical Thrombectomy, 3) Decompressive hemicraniectomy, 4) Antiplatelet treatment, 5) Anticoagulant treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -</measure>
    <time_frame>at 3-month</time_frame>
    <description>- Number of patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -</measure>
    <time_frame>at 3-month</time_frame>
    <description>- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting&#xD;
Intracerebral hemorrhage has to be proven by a brain CT Scan or MRI.&#xD;
Major systemic bleeding is defined according to Schulman et al., Journal of thrombosis and haemostasis, 2005.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Outcome assessed with the Modified Rankin Scale score.</measure>
    <time_frame>Between 3 to 6 months</time_frame>
    <description>The Modified Rankin Scale (MRS) is a single item overall outcome assessment scale for post-stroke patients. It is used to categorize the level of functional independence based on pre-stroke activities rather than on observing performance while performing a specific task. A higher score (range from 0 to 6) indicates a poorer outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack</measure>
    <time_frame>From inclusion to the end of follow-up: 3 to 6 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Carotid Arteries</condition>
  <arm_group>
    <arm_group_label>CAROtid WEB associated with cerebral infarction</arm_group_label>
    <description>french multicentric cohort that collects retrospectively and prospectively purely observational data on patients with cerebral infarction associated with a carotid web. Diagnostic, therapeutic or follow-up strategies will be at the discretion of the Stroke Unit taking care of the patient.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years of age, with imagery available by Angioscanner, Angio-MRI, or&#xD;
        arteriography and revealing the presence of a carotid web, with a cerebral infarction or&#xD;
        transient ischemic attack in the carotid territory downstream of a lesion of carotid web&#xD;
        viewed on a brain MRI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Available imaging revealing the presence of a carotid web&#xD;
&#xD;
          -  Cerebral infarction or transient ischemic attack in the carotid area downstream of a&#xD;
             carotid web lesion.&#xD;
&#xD;
          -  Validation of the carotid web by a pair of experts Neurologist and Neuroradiologist&#xD;
&#xD;
          -  Agreement of the patient or the support person given after reading the information and&#xD;
             non-opposition form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Patient expressing opposition to be enrolled in the CAROWEB cohort&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Stéphane OLINDO, M.D</last_name>
    <phone>05 57 82 12 63</phone>
    <email>stephane.olindo@chu-bordeaux.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aurore CAPELLI, PhD</last_name>
    <phone>05 57 82 08 77</phone>
    <email>aurore.capelli@chu-bordeaux.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stéphane OLINDO, MD</last_name>
      <phone>05 57 82 12 63</phone>
      <email>stephane.olindo@chu-bordeaux.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carotid Web</keyword>
  <keyword>Cerebral Infarction</keyword>
  <keyword>Cohort</keyword>
  <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/NCT04431609
org study id: CHUBX 2018/40
nct id: NCT04431609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Carotid Web located at the bulb level is a rare condition and is often associated with severe
      cerebral infarction in the carotid territory. This condition has been described predominantly
      in the black population. However, limited data are available for the epidemiology of carotid
      web and often result from selected population studies. It has been shown that the carotid web
      is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients
      treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed
      including in stroke unit. We assume that the implementation of a multicentric cohort would
      allow a comprehensive analysis of the carotid web condition.
Carotid web lesions associated with cerebral infarctions are a relatively rare and largely
      unknown disease. However, carotid web lesions are associated with severe infarction involving
      the functional and vital prognosis of patients. The high rate of recurrence should lead to an
      identification of the lesion at the first event in order to propose a suitable preventive
      treatment. We believe that only a multicenter cohort will be able to analyze the
      characteristics of the pathology and propose studies on critical size samples. A national
      cohort would lead quickly to a consequent collection of cases. By including overseas
      departments and communities, notions of prevalence and characteristics within different
      populations could finally be studied. Participation to the cohort constitution will probably
      lead to sensitizing the various actors of the course of stroke care to the diagnosis and
      appropriate care of the carotid web.

      Patients will be selected by the Stroke Units which take part in the cohort constitution.
      Stroke Unit investigator will fill the WEPI online entry database. Clinical, imaging and
      outcome characteristics will be informed.

      In order to guarantee the quality of the cases collected, the validation of the carotid web
      lesion will be carried out by a pair of expert Neurologist - Neuroradiologist appointed
      within an expert committee. In case of no consensus, a third expert will resolve the
      disagreement.
observational model: Cohort
time perspective: Prospective
measure: Number of patients included and validated by the expert committee at the end of the inclusion period
time frame: At 3 years
description: The missing data concerning clinical data, therapy used and functional prognosis between 3 and 6 months should be <10%. Each item entered in the eCRF can be answered. The lack of response will be considered as missing data in the patient's file.
measure: Demographics collected at the inclusion
time frame: at the inclusion
description: Age, Sex, Ethnic group based on self-determination
measure: NIHSS score at the admission in the neurological unit
time frame: at the inclusion
description: NIHSS scale (National Institute of Health Stroke Score) was described by T. Brott, in 1989, for used to assess patients with acute ischemic stroke. It can be used in carotid and vertebrobasilar ischemic attacks. The passing time of the scale is 6 minutes 30 on average. The NIHSS Score ranges from 0 to 42. A higher score indicates a worse clinical status.
measure: Radiological of the cerebral infarction collected at the inclusion
time frame: Web measurements carried out by 2 experts one month after the inclusion
description: localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
measure: Radiological of the cerebral infarction collected one month after the inclusion
time frame: Web measurements carried out by 2 experts one month after the inclusion
description: localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
measure: Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment
time frame: at the inclusion
description: Number of patients treated with: 1) Thrombolysis, 2) Mechanical Thrombectomy, 3) Decompressive hemicraniectomy, 4) Antiplatelet treatment, 5) Anticoagulant treatment
measure: Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -
time frame: at 3-month
description: - Number of patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting
measure: Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -
time frame: at 3-month
description: - Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting
Intracerebral hemorrhage has to be proven by a brain CT Scan or MRI.
Major systemic bleeding is defined according to Schulman et al., Journal of thrombosis and haemostasis, 2005.
measure: Stroke Outcome assessed with the Modified Rankin Scale score.
time frame: Between 3 to 6 months
description: The Modified Rankin Scale (MRS) is a single item overall outcome assessment scale for post-stroke patients. It is used to categorize the level of functional independence based on pre-stroke activities rather than on observing performance while performing a specific task. A higher score (range from 0 to 6) indicates a poorer outcome.
measure: Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack
time frame: From inclusion to the end of follow-up: 3 to 6 years
arm group label: CAROtid WEB associated with cerebral infarction
description: french multicentric cohort that collects retrospectively and prospectively purely observational data on patients with cerebral infarction associated with a carotid web. Diagnostic, therapeutic or follow-up strategies will be at the discretion of the Stroke Unit taking care of the patient.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Stéphane OLINDO, M.D
phone: 05 57 82 12 63
email: stephane.olindo@chu-bordeaux.fr
last name: Aurore CAPELLI, PhD
phone: 05 57 82 08 77
email: aurore.capelli@chu-bordeaux.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Infarction
mesh term: Infarction