<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/NCT04433455</url>
  </required_header>
  <id_info>
    <org_study_id>KY2019-465</org_study_id>
    <nct_id>NCT04433455</nct_id>
  </id_info>
  <brief_title>Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients</brief_title>
  <official_title>Influencing Factors of Cerebrovascular Disease and Cognition in Hemodialysis Patients: an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan 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>
      In this observational study, the investigators evaluate the influencing factors of&#xD;
      cerebrovascular disease and cognition in hemodialysis patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</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>cerebrovascular disease</measure>
    <time_frame>5 years</time_frame>
    <description>Magnetic resonance images will be used to determine the severity of white matter hyperintensity, using the Scheltens scale. Score 2 or more is abnormal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in cognitive function</measure>
    <time_frame>5 years</time_frame>
    <description>The Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows:&#xD;
25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementiaThe Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementia</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hemodialysis</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Cerebrovascular Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        maintenance hemodialysis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. maintenance hemodialysis patients who are younger than 85 years old and older than 50&#xD;
             years old, regardless of gender&#xD;
&#xD;
          2. dialysis vintage is greater than 3 months;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with severe infection and anemia (Hb &lt;60g / L);&#xD;
&#xD;
          2. Those with severe mental illness, metabolic diseases and immune system diseases;&#xD;
&#xD;
          3. Patients with abnormal liver function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jing Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jing Chen</last_name>
    <phone>862152889325</phone>
    <email>chenjing1998@fudan.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qian Zhang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Chen Jing</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</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/NCT04433455
org study id: KY2019-465
nct id: NCT04433455
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this observational study, the investigators evaluate the influencing factors of
      cerebrovascular disease and cognition in hemodialysis patients.
observational model: Cohort
time perspective: Prospective
measure: cerebrovascular disease
time frame: 5 years
description: Magnetic resonance images will be used to determine the severity of white matter hyperintensity, using the Scheltens scale. Score 2 or more is abnormal.
measure: changes in cognitive function
time frame: 5 years
description: The Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows:
25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementiaThe Mini-Mental State Examination (MMSE) will be used to assess the changes in cognitive function.The MMSE has a maximum score of 30 points. The scores are generally grouped as follows: 25-30 points: normal cognition 21-24 points: mild dementia 10-20 points: moderate dementia 9 points or lower: severe dementia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jing Chen
role: Principal Investigator
affiliation: Huashan Hospital
last name: Jing Chen
phone: 862152889325
email: chenjing1998@fudan.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Chen Jing
investigator title: Professor
mesh term: Cerebrovascular Disorders