<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/NCT03273179</url>
  </required_header>
  <id_info>
    <org_study_id>CVST-RCAS</org_study_id>
    <nct_id>NCT03273179</nct_id>
  </id_info>
  <brief_title>Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment Scales</brief_title>
  <official_title>Cerebral Venous Sinus Thrombosis: Re-exploration of Clinical Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</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>
      This is a single-center, retrospective, open-label study. This study is planned to&#xD;
      investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and&#xD;
      papilledema grade in assessing cerebral venous sinus thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2018</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>baseline CSF pressure</measure>
    <time_frame>baseline</time_frame>
    <description>CSF pressure at baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline mRS</measure>
    <time_frame>baseline</time_frame>
    <description>mRS at baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline papilledema grade</measure>
    <time_frame>baseline</time_frame>
    <description>Frisen grade of papilledema at baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>baseline NIHSS</measure>
    <time_frame>baseline</time_frame>
    <description>NIH Stroke Scale at baseline</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cerebral Venous Sinus Thrombosis</condition>
  <condition>CSF Pressure Increased</condition>
  <condition>Papilledema</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All individual with confirmed diagnosis of CVST are eligible for this research&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnosis of CVST by head MRI, DSA or MRV onset of CVST within one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to complete examinations unable to complete follow-ups&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Xunming Ji</last_name>
    <phone>+86-83198952</phone>
    <email>jixunming@vip.163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhen Zhang</last_name>
    <email>gzhenzhang@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhang Zhen</last_name>
      <email>gzhenzhang@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Ji Xunming</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cerebral venous sinus thrombosis</keyword>
  <keyword>CSF pressure</keyword>
  <keyword>modified Rankin Scale</keyword>
  <keyword>papilledema</keyword>
  <keyword>NIHSS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinus Thrombosis, Intracranial</mesh_term>
    <mesh_term>Papilledema</mesh_term>
    <mesh_term>Intracranial Hypertension</mesh_term>
    <mesh_term>Thrombosis</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/NCT03273179
org study id: CVST-RCAS
nct id: NCT03273179
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a single-center, retrospective, open-label study. This study is planned to
      investigate the accuracy of mRS and NIHSS, comparing with the accuracy of CSF pressure and
      papilledema grade in assessing cerebral venous sinus thrombosis.
observational model: Case-Only
time perspective: Retrospective
measure: baseline CSF pressure
time frame: baseline
description: CSF pressure at baseline
measure: baseline mRS
time frame: baseline
description: mRS at baseline
measure: baseline papilledema grade
time frame: baseline
description: Frisen grade of papilledema at baseline
measure: baseline NIHSS
time frame: baseline
description: NIH Stroke Scale at baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Xunming Ji
phone: +86-83198952
email: jixunming@vip.163.com
last name: Zhen Zhang
email: gzhenzhang@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: Professor
mesh term: Sinus Thrombosis, Intracranial
mesh term: Papilledema
mesh term: Intracranial Hypertension
mesh term: Thrombosis