<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/NCT03773627</url>
  </required_header>
  <id_info>
    <org_study_id>2017-075</org_study_id>
    <nct_id>NCT03773627</nct_id>
  </id_info>
  <brief_title>MRI Maker of Perioperative Neurocognitive Disorder</brief_title>
  <acronym>MRIPND</acronym>
  <official_title>MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</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>
      Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity&#xD;
      and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the&#xD;
      prediction or diagnosis of the development of delayed neurocognitive recovery in aged&#xD;
      patients have not been identified so far. The purpose of this study is trying to find the&#xD;
      functional MRI marker of PND.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</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>MRI markers of PND before 7th day after surgery</measure>
    <time_frame>From the day before surgery to the 7th day after surgery</time_frame>
    <description>To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRI markers of PND before 12 month after surgery</measure>
    <time_frame>From the 7th day after surgery to 12 month after surgery</time_frame>
    <description>To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Necrosis of Femoral Head</condition>
  <condition>Knee Osteoarthritis</condition>
  <condition>Fracture of Lower Limb</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients elder than 60 years old elective to undergo lower limb surgery and conform to the&#xD;
        including criteria would be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Spoke proficient Chinese&#xD;
&#xD;
          -  Selected to lower limb osteopathic surgery&#xD;
&#xD;
          -  Informed consent signed by the patient&#xD;
&#xD;
          -  Underwent general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Existing cerebral disease, or have a history of neurological and psychiatric diseases&#xD;
             including AD, stroke, and psychosis&#xD;
&#xD;
          -  Existing cognitive impairment as evidenced by Mini-Mental State Examination scores&#xD;
             below 24&#xD;
&#xD;
          -  Several audition or vision disorder&#xD;
&#xD;
          -  With standard contraindications to MRI examinations&#xD;
&#xD;
          -  Unwillingness to comply with the protocol or procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>qi lu, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diansan Su, Dr.</last_name>
    <phone>+862168383702</phone>
    <email>diansansu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diansan Su</last_name>
      <phone>+862168383702</phone>
      <email>diansansu@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Linke Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03773627
org study id: 2017-075
nct id: NCT03773627
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity
      and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the
      prediction or diagnosis of the development of delayed neurocognitive recovery in aged
      patients have not been identified so far. The purpose of this study is trying to find the
      functional MRI marker of PND.
observational model: Cohort
time perspective: Prospective
measure: MRI markers of PND before 7th day after surgery
time frame: From the day before surgery to the 7th day after surgery
description: To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 7th day after surgery
measure: MRI markers of PND before 12 month after surgery
time frame: From the 7th day after surgery to 12 month after surgery
description: To analysis the association of volume of hippocampus measured by MRI and the occurrence of PND identified at the 12 months after surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: qi lu, Dr.
role: Study Director
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
last name: Diansan Su, Dr.
phone: +862168383702
email: diansansu@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Necrosis
sharing ipd: Undecided