<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/NCT04443439</url>
  </required_header>
  <id_info>
    <org_study_id>2018LCYJ005</org_study_id>
    <nct_id>NCT04443439</nct_id>
  </id_info>
  <brief_title>Assess the Risk of Cerebrovascular Disease</brief_title>
  <official_title>Head and Neck CTA Combined With Multimodal MRI to Assess the Risk of Cerebrovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tang-Du 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>
      Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of&#xD;
      intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke.&#xD;
      Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms&#xD;
      of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not&#xD;
      happen cerebrovascular events such as stroke, but there have been a different degree of&#xD;
      cognitive impairment, be badly in need of development of noninvasive imaging methods,&#xD;
      objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of&#xD;
      ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA,&#xD;
      double modal MRI techniques, clinical and biochemical indicator detection, mathematical&#xD;
      modeling and statistical analysis techniques, assess the ACS group and normal person the&#xD;
      cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of&#xD;
      ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the&#xD;
      correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of&#xD;
      ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the&#xD;
      series of indicators and specific degrees.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment</measure>
    <time_frame>2020.01</time_frame>
    <description>The Montreal cognitive assessment (MoCA) scale was used to evaluate the differences in cognitive function between ACS and the healthy control group in different dimensions, and the horizontal correlation analysis between ACS and cognitive impairment was conducted according to the dimensions of cognitive impairment and the degree of ACS.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cerebrovascular Disease</condition>
  <arm_group>
    <arm_group_label>No related neurological symptoms and transient ischemic attack</arm_group_label>
    <description>Mild stenosis group: CTA suggested carotid stenosis &lt; 30%; Moderate stenosis group: CTA suggested carotid stenosis of 30-69%; Severe stenosis group: CTA indicated carotid stenosis ≥70%;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GE Discovery MR750 3.0t superconducting MRI</intervention_name>
    <description>T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions</description>
    <arm_group_label>No related neurological symptoms and transient ischemic attack</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        No carotid stenosis - related neurological symptoms and transient ischemic attacks (50&#xD;
        patients in each group, 25 males and 25 females).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Mild stenosis group: CTA suggested carotid stenosis &lt; 30%;&#xD;
&#xD;
          2. Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;&#xD;
&#xD;
          3. Severe stenosis group: CTA indicated carotid stenosis ≥70%;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. dementia, MMSE score &lt; 21;&#xD;
&#xD;
          2. previous carotid stenosis related neurological symptoms or transient ischemic attack;&#xD;
&#xD;
          3. other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and&#xD;
             complications of great vessels (cerebral infarction or cerebral malacia);&#xD;
&#xD;
          4. contraindications for MRI examination;&#xD;
&#xD;
          5. recent use of psychoactive drugs or hormones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wen Wang, Ph.D.</last_name>
    <phone>+8618629066628</phone>
    <phone_ext>+8618629066628</phone_ext>
    <email>wangwen@fmmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wen Wang</name>
      <address>
        <city>Xi'an</city>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wen Wang, Ph.D.</last_name>
      <phone>+8618629066628</phone>
      <phone_ext>+8618629066628</phone_ext>
      <email>wangwen@fmmu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 23, 2022</last_update_submitted>
  <last_update_submitted_qc>October 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tang-Du Hospital</investigator_affiliation>
    <investigator_full_name>Wen Wang, MD &amp; PhD</investigator_full_name>
    <investigator_title>Director of radiology</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04443439/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04443439/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04443439/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04443439
org study id: 2018LCYJ005
nct id: NCT04443439
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of
      intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke.
      Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms
      of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not
      happen cerebrovascular events such as stroke, but there have been a different degree of
      cognitive impairment, be badly in need of development of noninvasive imaging methods,
      objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of
      ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA,
      double modal MRI techniques, clinical and biochemical indicator detection, mathematical
      modeling and statistical analysis techniques, assess the ACS group and normal person the
      cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of
      ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the
      correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of
      ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the
      series of indicators and specific degrees.
observational model: Case-Control
time perspective: Prospective
measure: Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment
time frame: 2020.01
description: The Montreal cognitive assessment (MoCA) scale was used to evaluate the differences in cognitive function between ACS and the healthy control group in different dimensions, and the horizontal correlation analysis between ACS and cognitive impairment was conducted according to the dimensions of cognitive impairment and the degree of ACS.
arm group label: No related neurological symptoms and transient ischemic attack
description: Mild stenosis group: CTA suggested carotid stenosis < 30%; Moderate stenosis group: CTA suggested carotid stenosis of 30-69%; Severe stenosis group: CTA indicated carotid stenosis ≥70%;
intervention type: Device
intervention name: GE Discovery MR750 3.0t superconducting MRI
description: T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions
arm group label: No related neurological symptoms and transient ischemic attack
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wen Wang, Ph.D.
phone: +8618629066628
phone ext: +8618629066628
email: wangwen@fmmu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tang-Du Hospital
investigator full name: Wen Wang, MD & PhD
investigator title: Director of radiology
mesh term: Cerebrovascular Disorders
provided document: 
provided document: 
provided document: 