<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/NCT04492332</url>
  </required_header>
  <id_info>
    <org_study_id>BTSS-ICP</org_study_id>
    <nct_id>NCT04492332</nct_id>
  </id_info>
  <brief_title>Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis</brief_title>
  <official_title>Influencing Factors of Intracranial Hypertension in Patients With Bilateral Transverse Sinus Stenosis</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>
      Bilateral transverse sinus stenosis (BTSS) is associated with intracranial hypertension (IH).&#xD;
      However, not every BTSS patients presented with IH. The risk factors of IH in BTSS patients&#xD;
      remained obscure. Vertebral venous collaterals (VVC) were often found in patients with&#xD;
      bilateral transverse sinus stenosis (BTSS). The purpose of this study was to investigate the&#xD;
      physiological role of VVC in BTSS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bilateral transverse sinus stenosis (BTSS) is characterized by narrowing of bilateral&#xD;
      transverse sinus which resulted in obstruction of venous reflux. The majority of BTSS&#xD;
      patients exhibited with intracranial hypertension (IH) which manifested as a triad of&#xD;
      headaches, tinnitus and papilledema. Stenting improved the symptoms in patients with&#xD;
      transverse sinus stenosis (TSS) and reduced the elevated intracranial pressure (ICP). It is&#xD;
      suggested that BTSS is one of the etiologies of IH. Since an alternative pattern of venous&#xD;
      reflux was observed in patients with occluded superior sagittal sinus, it is postulated that&#xD;
      altered pattern of venous reflux also exists in the presence of BTSS. The drainage of&#xD;
      cerebral veins consists of two major pathways: transverse sinus-sigmoid sinus-internal&#xD;
      jugular vein and vertebral venous plexus. Vertebral venous plexus is an extensive&#xD;
      paravertebral system that provides direct venous communication between peritoneum and cranial&#xD;
      cavity. The presence of vertebral venous collaterals (VVC) was reported in 108 consecutive&#xD;
      patients. However, whether VVC is of physiological significance in BTSS patients remained&#xD;
      unknown. This study was aimed to investigate the physiological role of VVC and whether it is&#xD;
      involved in the regulation of IH and related clinical symptoms in BTSS patients.&#xD;
&#xD;
      Besides, it is presumed that serum uric acid (UA) may affect the formation of vertebral&#xD;
      venous collaterals (VVC) and intracranial pressure (ICP). It is reported that UA inhibits the&#xD;
      endothelial NO biological activity. High concentrations of uric acid (UA) suppresses&#xD;
      circulating VEGF in Wistar rats and VEGF secretion in human endothelial cells. It is presumed&#xD;
      that serum UA may affect the formation of VVC and ICP. The aim of this study is to&#xD;
      investigate whether serum UA serves as an influencing factor of VVC and an indicator of IH in&#xD;
      BTSS patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intracranial pressure (ICP)</measure>
    <time_frame>at admission</time_frame>
    <description>ICP was detected by standard lumbar puncture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>serum uric acid (UA)</measure>
    <time_frame>at admission</time_frame>
    <description>Fasting venous blood was withdrawn simultaneously to assess serum UA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Triad of IH: papilledema</measure>
    <time_frame>at admission</time_frame>
    <description>Fundus photography was graded by using modified Frisén's grade</description>
  </other_outcome>
  <other_outcome>
    <measure>Triad of IH: headache</measure>
    <time_frame>at admission</time_frame>
    <description>10-point Numeric Pain Rating Scale (NPRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Triad of IH: tinnitus</measure>
    <time_frame>at admission</time_frame>
    <description>questionnaires for tinnitus handicap inventory (THI)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Vertebral Venous Collaterals</condition>
  <condition>Serum Uric Acid</condition>
  <condition>Intracranial Hypertension</condition>
  <condition>Bilateral Transverse Sinus Stenosis</condition>
  <arm_group>
    <arm_group_label>normal controls with VVC</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis &gt;2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal controls without VVC</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis &gt;2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BTSS patients with VVC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis &gt;2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BTSS patients without VVC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis &gt;2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>standard lumbar puncture</intervention_name>
    <description>Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.</description>
    <arm_group_label>BTSS patients with VVC</arm_group_label>
    <arm_group_label>BTSS patients without VVC</arm_group_label>
    <arm_group_label>normal controls with VVC</arm_group_label>
    <arm_group_label>normal controls without VVC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BTSS confirmed by two of magnetic resonance venography (MRV), computed tomography&#xD;
             venography (CTV) or digital subtraction angiography (DSA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medicine related intracranial hypertension;&#xD;
&#xD;
          -  systemic inflammation;&#xD;
&#xD;
          -  moderate to severe stenosis in intracranial, carotid or vertebral arteries;&#xD;
&#xD;
          -  moderate to severe stenosis in intracranial or jugular veins other than transverse&#xD;
             sinus;&#xD;
&#xD;
          -  intracranial lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xuanwu Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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,MD,PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>vertebral venous collaterals</keyword>
  <keyword>serum uric acid</keyword>
  <keyword>Bilateral transverse sinus stenosis</keyword>
  <keyword>intracranial hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT04492332
org study id: BTSS-ICP
nct id: NCT04492332
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Bilateral transverse sinus stenosis (BTSS) is associated with intracranial hypertension (IH).
      However, not every BTSS patients presented with IH. The risk factors of IH in BTSS patients
      remained obscure. Vertebral venous collaterals (VVC) were often found in patients with
      bilateral transverse sinus stenosis (BTSS). The purpose of this study was to investigate the
      physiological role of VVC in BTSS patients.
Bilateral transverse sinus stenosis (BTSS) is characterized by narrowing of bilateral
      transverse sinus which resulted in obstruction of venous reflux. The majority of BTSS
      patients exhibited with intracranial hypertension (IH) which manifested as a triad of
      headaches, tinnitus and papilledema. Stenting improved the symptoms in patients with
      transverse sinus stenosis (TSS) and reduced the elevated intracranial pressure (ICP). It is
      suggested that BTSS is one of the etiologies of IH. Since an alternative pattern of venous
      reflux was observed in patients with occluded superior sagittal sinus, it is postulated that
      altered pattern of venous reflux also exists in the presence of BTSS. The drainage of
      cerebral veins consists of two major pathways: transverse sinus-sigmoid sinus-internal
      jugular vein and vertebral venous plexus. Vertebral venous plexus is an extensive
      paravertebral system that provides direct venous communication between peritoneum and cranial
      cavity. The presence of vertebral venous collaterals (VVC) was reported in 108 consecutive
      patients. However, whether VVC is of physiological significance in BTSS patients remained
      unknown. This study was aimed to investigate the physiological role of VVC and whether it is
      involved in the regulation of IH and related clinical symptoms in BTSS patients.

      Besides, it is presumed that serum uric acid (UA) may affect the formation of vertebral
      venous collaterals (VVC) and intracranial pressure (ICP). It is reported that UA inhibits the
      endothelial NO biological activity. High concentrations of uric acid (UA) suppresses
      circulating VEGF in Wistar rats and VEGF secretion in human endothelial cells. It is presumed
      that serum UA may affect the formation of VVC and ICP. The aim of this study is to
      investigate whether serum UA serves as an influencing factor of VVC and an indicator of IH in
      BTSS patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: intracranial pressure (ICP)
time frame: at admission
description: ICP was detected by standard lumbar puncture
measure: serum uric acid (UA)
time frame: at admission
description: Fasting venous blood was withdrawn simultaneously to assess serum UA.
measure: Triad of IH: papilledema
time frame: at admission
description: Fundus photography was graded by using modified Frisén's grade
measure: Triad of IH: headache
time frame: at admission
description: 10-point Numeric Pain Rating Scale (NPRS)
measure: Triad of IH: tinnitus
time frame: at admission
description: questionnaires for tinnitus handicap inventory (THI)
arm group label: normal controls with VVC
arm group type: Sham Comparator
description: BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found.
arm group label: normal controls without VVC
arm group type: Sham Comparator
description: BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found.
arm group label: BTSS patients with VVC
arm group type: Active Comparator
description: BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were found.
arm group label: BTSS patients without VVC
arm group type: Active Comparator
description: BTSS was confirmed by two of magnetic resonance venography (MRV), computed tomography venography (CTV) or digital subtraction angiography (DSA). The index of TSS (ITSS) score was a useful tool for the assessment of BTSS severity. The degree of stenosis was graded from 0 to 4 based on the following scale: 0 = normal; 1 = stenosis up to 1/3; 2 = stenosis between 1/3 and 2/3; 3 = stenosis >2/3; and 4 = hypoplasia. ITSS was calculated as degree of right TSS × degree of left TSS. Vertebral venous collaterals (VVC) were not found.
intervention type: Diagnostic Test
intervention name: standard lumbar puncture
description: Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.
arm group label: BTSS patients with VVC
arm group label: BTSS patients without VVC
arm group label: normal controls with VVC
arm group label: normal controls without VVC
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming,MD,PhD
investigator title: Professor
mesh term: Intracranial Hypertension
mesh term: Hypertension
mesh term: Constriction, Pathologic