<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/NCT03246373</url>
  </required_header>
  <id_info>
    <org_study_id>CSA2016KY001</org_study_id>
    <nct_id>NCT03246373</nct_id>
  </id_info>
  <brief_title>the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population</brief_title>
  <official_title>Prospective, Single Center, Observational, Clinical Trial of the Effects of Cerebral Collateral Circulation on the Outcome of Leukoaraiosis in High-risk Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      This study observed the relationship between cerebral collateral circulation and the&#xD;
      prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and&#xD;
      leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The&#xD;
      participants' clinical performance caused by leukoaraiosis will be assessed by a series of&#xD;
      scales.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Case collection information is sent daily to clinical trial supervisors.&#xD;
&#xD;
        2. The clinical trial team meets once a week to monitor the quality of clinical trials.&#xD;
&#xD;
        3. The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score&#xD;
           is more than 2 will take additional magnetic resonance examination including magnetic&#xD;
           resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive&#xD;
           ability will be evaluated by a series of scales including Mini-Mental State Examination&#xD;
           (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical&#xD;
           performance battery (SPPB).&#xD;
&#xD;
           The blood sample will be taken for biochemical detection and hair and nail samples for&#xD;
           trace element detection.&#xD;
&#xD;
        4. Data were analyzed by regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>1 Year</target_duration>
  <primary_outcome>
    <measure>change in cognitive assessment scale score</measure>
    <time_frame>baseline and one year</time_frame>
    <description>It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in mood assessment Scale score</measure>
    <time_frame>baseline and one year</time_frame>
    <description>It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in gait evaluation score</measure>
    <time_frame>baseline and one year</time_frame>
    <description>It will be assessed by the short physical performance battery (SPPB). It is scored 0-11.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke</measure>
    <time_frame>baseline and one year</time_frame>
    <description>The participant is diagnosed with stroke</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1037</enrollment>
  <condition>Leukoaraiosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample fingernail sample hair sample urinary sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients of physical exmination department or out-patients of neurology department in&#xD;
        Zhongshan hospital Fudan University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical Examinees or out-patients&#xD;
&#xD;
          -  The MRI scale score ≥ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  History of malignant tumor&#xD;
&#xD;
          -  History of connective tissue disease&#xD;
&#xD;
          -  Pregnant, trying to become pregnant or within 6 weeks after delivery&#xD;
&#xD;
          -  serious infections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>neurology department of Zhongshan hospital, Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anyan Ge</last_name>
    <phone>862164041990</phone>
    <phone_ext>2976</phone_ext>
    <email>ge.anyan@zs-hospital.sh.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jing Ding</last_name>
    <phone>8664041990</phone>
    <phone_ext>12119</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>neurology department of Zhongshan hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anyan Ge</last_name>
      <phone>8664041990</phone>
      <email>ge.anyan@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukoaraiosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246373
org study id: CSA2016KY001
nct id: NCT03246373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study observed the relationship between cerebral collateral circulation and the
      prognosis of leukoaraiosis in high-risk population. Cerebral collateral circulation and
      leukoaraiosis levels will be evaluated and followed up by magnetic resonance examination. The
      participants' clinical performance caused by leukoaraiosis will be assessed by a series of
      scales.
1. Case collection information is sent daily to clinical trial supervisors.

        2. The clinical trial team meets once a week to monitor the quality of clinical trials.

        3. The severity of the leukoaraiosis will be evaluated by a scale. The patients whose score
           is more than 2 will take additional magnetic resonance examination including magnetic
           resonance angiography (MRA) and arterial spin labeling (ASL). And their cognitive
           ability will be evaluated by a series of scales including Mini-Mental State Examination
           (MMSE) and Montreal cognitive assessment (MoCA) and gait by the short physical
           performance battery (SPPB).

           The blood sample will be taken for biochemical detection and hair and nail samples for
           trace element detection.

        4. Data were analyzed by regression analysis.
observational model: Cohort
time perspective: Prospective
measure: change in cognitive assessment scale score
time frame: baseline and one year
description: It will be assessed by the Mini-Mental state examination (MMSE) and Montreal cognitive assessment (MoCA). Each assessment is scored 0-30, yielding a total between 0-60.
measure: change in mood assessment Scale score
time frame: baseline and one year
description: It will be assessed by Hamilton Depression Scale (HAMD). It is scored 0-30.
measure: change in gait evaluation score
time frame: baseline and one year
description: It will be assessed by the short physical performance battery (SPPB). It is scored 0-11.
measure: stroke
time frame: baseline and one year
description: The participant is diagnosed with stroke
blood sample fingernail sample hair sample urinary sample
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xin Wang
role: Principal Investigator
affiliation: neurology department of Zhongshan hospital, Fudan University
last name: Anyan Ge
phone: 862164041990
phone ext: 2976
email: ge.anyan@zs-hospital.sh.cn
last name: Jing Ding
phone: 8664041990
phone ext: 12119
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukoaraiosis
sharing ipd: No