<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/NCT04443933</url>
  </required_header>
  <id_info>
    <org_study_id>KY2019-147</org_study_id>
    <nct_id>NCT04443933</nct_id>
  </id_info>
  <brief_title>Cerebral Small Vessel Disease and Perioperative Covert Stroke</brief_title>
  <acronym>MOCSS</acronym>
  <official_title>A Multicenter Prospective Cohort Study of Multimodal MRI in Cerebral Small Vessel Disease and Covert Stroke in Perioperative Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS&#xD;
      study is to investigate whether there is a correlation between the preoperative cerebral&#xD;
      small vessel disease and the incidence of covert stroke after non-cardiac surgery. Cerebral&#xD;
      small vessel disease (CSVD) and covert stroke will be diagnosed using multimodal MRI. This&#xD;
      study will also investigate whether preoperative CSVD and postoperative covert stroke are&#xD;
      related to postoperative cognitive dysfunction and delirium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the growing number of the older population, surgery for elderly patients is on the rise.&#xD;
      Elderly patients often have more cardiovascular disease and brain vulnerability and tend to&#xD;
      experience more perioperative complications. Perioperative covert stroke is one of those that&#xD;
      can been neglected for a long time and is associated with long-term cognitive impairment.&#xD;
      While CSVD is an insidious disease mainly affecting small blood vessels in the brain with&#xD;
      variable symptoms including dementia, cognitive decline, gait impairment, mood disturbance&#xD;
      and stroke. According to the etiopathology of CSVD, there's a possibility that CSVD is a&#xD;
      potential risk factor for covert stroke and it may serve as a predictive marker for cognitive&#xD;
      decline after surgery.&#xD;
&#xD;
      In this multicenter prospective clinical cohort study, the investigators aim to investigate&#xD;
      the correlation between the MRI manifestations of cerebral small vessel disease and&#xD;
      perioperative covert stroke.&#xD;
&#xD;
      Patients aged between 65 to 85 who are scheduled for elective non-cardiac surgeries will be&#xD;
      enrolled.The primary outcome is the incidence of perioperative covert stroke diagnosed by&#xD;
      MRI. Secondary outcomes include incidence of delirium (using ICU-CAM) within 3 days after&#xD;
      surgery and cognitive function tests (using Mini-Mental State Examination and Montreal&#xD;
      Cognitive Assessment), physical function test (using ADL, Activities of Daily Living) and&#xD;
      dependence test (using modified Rankin Scale) at 3 months, 6 months and 12months after&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Incidence of postoperative covert stroke</measure>
    <time_frame>14 days</time_frame>
    <description>We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of overt stroke after surgery</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>Incidence of overt stroke will be measured by obtaining medical history.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale after surgery</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>The Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people after stroke or other neurological disability.Minimum value:0, Maximum value:6. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function assessed by Montreal Cognitive Assessment Scale</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>We will use Montreal Cognitive Assessment (MoCA) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function assessed by Mini-Mental State Examination Scale</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>We will use Mini-Mental State Examination (MMSE) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of delirium</measure>
    <time_frame>72 hours</time_frame>
    <description>Incidence of delirium will be measured using Intensive Care Unit-Cognitive Assessment Method (ICU-CAM) every 12 hours till the 72 hours after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functions after surgery</measure>
    <time_frame>3 months, 6 months and 12 months</time_frame>
    <description>The investigators will use Activities of daily living (ADL) scale to measure physical function after surgery. Minimum value:0, Maximum value: 78. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">548</enrollment>
  <condition>Cerebral Small Vessel Diseases</condition>
  <condition>Covert Postoperative Stroke</condition>
  <arm_group>
    <arm_group_label>Cerebral Small Vessel Disease</arm_group_label>
    <description>In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-Cerebral Small Vessel Disease</arm_group_label>
    <description>In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      5 ml peripheral venous blood samples will be taken before the surgery. The blood samples will&#xD;
      be preserved in ethylenediaminetetraacetic acid tubes and patient's information and serial&#xD;
      number will be recorded on the tube. Samples are centrifuged for 10min at 2000x g and the&#xD;
      supernatants will be transformed into Eppendorf tubes and stored at -80 °C. DNA will be&#xD;
      extracted according to the protocol. The DNA samples will be stored at -80°C until further&#xD;
      use. Before taking blood from patients, the purpose of using blood samples will be fully&#xD;
      explained to them and informed consent will be obtained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll patients aged from 65 to 85 years old who are scheduled for elective&#xD;
        non-cardiac surgery and have signed informed consent before the surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 65 years to 85 years;&#xD;
&#xD;
          -  The patient is about to have major surgery for the first time and the operation is&#xD;
             non-cardiac surgery;&#xD;
&#xD;
          -  Written informed consent is obtained before the surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental illness;&#xD;
&#xD;
          -  Already have other diseases that can cause dementia, such as Alzheimer's disease, Lewy&#xD;
             body dementia, Frontotemporal dementia, progressive supranuclear palsy, Parkinson's&#xD;
             disease, Creutzfeldt-Jakob disease, Huntington's disease, alcohol and drug dependence,&#xD;
             Neurosyphilis, systemic lupus erythematosus; or preoperative MRI shows hippocampal and&#xD;
             temporal lobe atrophy more than two levels, suggesting the possibility of Alzheimer's&#xD;
             disease&#xD;
&#xD;
          -  Have suffered from other brain diseases (such as stroke, multiple sclerosis, central&#xD;
             nervous system infection with sequelae, etc.);&#xD;
&#xD;
          -  Preoperative MRI indicates covert stroke&#xD;
&#xD;
          -  MMSE or MoCA scale cannot be completed due to other reasons (such as hearing&#xD;
             impairment or visual impairment)&#xD;
&#xD;
          -  MRI contraindications before or after surgery or patients who cannot tolerate MRI&#xD;
             imaging&#xD;
&#xD;
          -  Stage 3 or 4 malignant tumors, and high malignancy and poor prognosis cancer, such as&#xD;
             pancreatic cancer, gallbladder cancer, and bile duct cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peiying Li, MD,PhD</last_name>
    <phone>8615800616866</phone>
    <email>peiyingli.md@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dan Huang, MD</last_name>
    <phone>862168383702</phone>
    <email>huangdan363@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Renji Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peiying Li, MD,PhD</last_name>
      <phone>8615800616866</phone>
      <email>peiyingli.md@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</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>Stroke</mesh_term>
    <mesh_term>Cerebral Small Vessel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication will be shared starting 6 months after publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>All the IPD and any additional supporting information will become available starting 6 months after publication for at least 5 years.</ipd_time_frame>
    <ipd_access_criteria>Requests to access all the IPD and additional supporting information will be addressed and reviewed by the corresponding author of the related publication. Access criteria include that the requests shall be submitted by a researcher on an institutional headed paper; the requests shall come with all the detailed contact information of the researcher and the administration office of the institution.</ipd_access_criteria>
  </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/NCT04443933
org study id: KY2019-147
nct id: NCT04443933
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
MOCSS study is a multicenter prospective clinical cohort study. The purpose of the MOCSS
      study is to investigate whether there is a correlation between the preoperative cerebral
      small vessel disease and the incidence of covert stroke after non-cardiac surgery. Cerebral
      small vessel disease (CSVD) and covert stroke will be diagnosed using multimodal MRI. This
      study will also investigate whether preoperative CSVD and postoperative covert stroke are
      related to postoperative cognitive dysfunction and delirium.
With the growing number of the older population, surgery for elderly patients is on the rise.
      Elderly patients often have more cardiovascular disease and brain vulnerability and tend to
      experience more perioperative complications. Perioperative covert stroke is one of those that
      can been neglected for a long time and is associated with long-term cognitive impairment.
      While CSVD is an insidious disease mainly affecting small blood vessels in the brain with
      variable symptoms including dementia, cognitive decline, gait impairment, mood disturbance
      and stroke. According to the etiopathology of CSVD, there's a possibility that CSVD is a
      potential risk factor for covert stroke and it may serve as a predictive marker for cognitive
      decline after surgery.

      In this multicenter prospective clinical cohort study, the investigators aim to investigate
      the correlation between the MRI manifestations of cerebral small vessel disease and
      perioperative covert stroke.

      Patients aged between 65 to 85 who are scheduled for elective non-cardiac surgeries will be
      enrolled.The primary outcome is the incidence of perioperative covert stroke diagnosed by
      MRI. Secondary outcomes include incidence of delirium (using ICU-CAM) within 3 days after
      surgery and cognitive function tests (using Mini-Mental State Examination and Montreal
      Cognitive Assessment), physical function test (using ADL, Activities of Daily Living) and
      dependence test (using modified Rankin Scale) at 3 months, 6 months and 12months after
      surgery.
observational model: Cohort
time perspective: Prospective
measure: Incidence of postoperative covert stroke
time frame: 14 days
description: We will use MRI to detect postoperative covert stroke as soon as patients can tolerate MRI.
measure: Incidence of overt stroke after surgery
time frame: 3 months, 6 months and 12 months
description: Incidence of overt stroke will be measured by obtaining medical history.
measure: Modified Rankin Scale after surgery
time frame: 3 months, 6 months and 12 months
description: The Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people after stroke or other neurological disability.Minimum value:0, Maximum value:6. Higher scores mean a worse outcome.
measure: Cognitive Function assessed by Montreal Cognitive Assessment Scale
time frame: 3 months, 6 months and 12 months
description: We will use Montreal Cognitive Assessment (MoCA) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.
measure: Cognitive Function assessed by Mini-Mental State Examination Scale
time frame: 3 months, 6 months and 12 months
description: We will use Mini-Mental State Examination (MMSE) scale to assess cognitive function after surgery. Minimum value:0, Maximum value: 30. Higher scores mean a better outcome.
measure: Incidence of delirium
time frame: 72 hours
description: Incidence of delirium will be measured using Intensive Care Unit-Cognitive Assessment Method (ICU-CAM) every 12 hours till the 72 hours after surgery.
measure: Physical functions after surgery
time frame: 3 months, 6 months and 12 months
description: The investigators will use Activities of daily living (ADL) scale to measure physical function after surgery. Minimum value:0, Maximum value: 78. Higher scores mean a better outcome.
arm group label: Cerebral Small Vessel Disease
description: In this group, patients are diagnosed with cerebral small vessel disease preoperatively using multimodal MRI.
arm group label: non-Cerebral Small Vessel Disease
description: In this group, cerebral small vessel disease is ruled out by preoperative multimodal MRI.
5 ml peripheral venous blood samples will be taken before the surgery. The blood samples will
      be preserved in ethylenediaminetetraacetic acid tubes and patient's information and serial
      number will be recorded on the tube. Samples are centrifuged for 10min at 2000x g and the
      supernatants will be transformed into Eppendorf tubes and stored at -80 °C. DNA will be
      extracted according to the protocol. The DNA samples will be stored at -80°C until further
      use. Before taking blood from patients, the purpose of using blood samples will be fully
      explained to them and informed consent will be obtained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Peiying Li, MD,PhD
phone: 8615800616866
email: peiyingli.md@gmail.com
last name: Dan Huang, MD
phone: 862168383702
email: huangdan363@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stroke
mesh term: Cerebral Small Vessel Diseases
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication will be shared starting 6 months after publication.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: All the IPD and any additional supporting information will become available starting 6 months after publication for at least 5 years.
ipd access criteria: Requests to access all the IPD and additional supporting information will be addressed and reviewed by the corresponding author of the related publication. Access criteria include that the requests shall be submitted by a researcher on an institutional headed paper; the requests shall come with all the detailed contact information of the researcher and the administration office of the institution.