<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/NCT03785171</url>
  </required_header>
  <id_info>
    <org_study_id>Multimodal MRI-Moyamoya</org_study_id>
    <nct_id>NCT03785171</nct_id>
  </id_info>
  <brief_title>Predicative Value of Multimodal MRI in Moyamoya Disease</brief_title>
  <official_title>Multimodal Magnetic Resonance Imaging Predicting Outcome After Surgical Revascularization in Patients With Moyamoya Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General 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>
      Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by&#xD;
      a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and&#xD;
      their proximal branches, with subsequent formation of collateral vessels (&quot;puff of smoke&quot;).&#xD;
      In some cases, the posterior circulation can also be involved. MMD has been discovered around&#xD;
      the world, but Asians carry the most possibility to develop this disease. Current treatment&#xD;
      designed to prevent strokes by improving blood flow to the affected cerebral hemisphere&#xD;
      including medical therapy and surgery. In particular, surgery included two general methods:&#xD;
      direct and indirect revascularization. Compared with direct bypass, indirect procedures are&#xD;
      more technically accessible and may reduce the possibility of complications, such as&#xD;
      hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have&#xD;
      shown great potential in evaluating perfusion in patients, and could possibly predict&#xD;
      surgical outcome. However, there is still lack of evidence of the predictive value of MRI in&#xD;
      evaluating clinical and angiography improvement in patients with MMD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Imaging protocols:&#xD;
&#xD;
      3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST&#xD;
&#xD;
      Imaging evaluation:&#xD;
&#xD;
        1. Transfer contrast volume value measured by DCE;&#xD;
&#xD;
        2. ASL shows CBF in associated regions;&#xD;
&#xD;
        3. Stoke area measured by DWI and Flair;&#xD;
&#xD;
        4. PH values reflected by APT-CEST.&#xD;
&#xD;
      Treatment:&#xD;
&#xD;
      Surgery-indirect revascularization&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
      Baseline (MRI+DSA); 3-months follow-up (MRI); 6-months follow-up (MRI+DSA)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 7, 2018</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Patients selection/stratification</measure>
    <time_frame>Three months to 6 months</time_frame>
    <description>Finding the effect of imaging biomarkers/patterns to provide therapy decision support</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical outcome</measure>
    <time_frame>Three months to 6 months</time_frame>
    <description>Finding the effect of imaging biomarkers/patterns to reflect modified Rankin scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical response</measure>
    <time_frame>Three months to 6 months</time_frame>
    <description>Finding the effect of imaging biomarkers/patterns to reflect revascularized blood flow</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Moyamoya Disease</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <arm_group>
    <arm_group_label>Moyamoya disease</arm_group_label>
    <description>The cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgical revascularization</intervention_name>
    <description>Indirect revascularization procedure</description>
    <arm_group_label>Moyamoya disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Moyamoya disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the&#xD;
             proximal portion of anterior/middle cerebral artery;&#xD;
&#xD;
          -  Abnormal vascular network appeared in the brain;&#xD;
&#xD;
          -  With the onset of cerebral ischemia/hemorrhage/TIA;&#xD;
&#xD;
          -  No cerebral infarction or cerebral hemorrhage occurred within the last month;&#xD;
&#xD;
          -  All MRI examination performed according to study protocol;&#xD;
&#xD;
          -  Signed informed consent obtained from the patient or patient's legally authorized&#xD;
             representative;&#xD;
&#xD;
          -  Having complete medical history and clinical follow up;&#xD;
&#xD;
          -  Imaging data can be processed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with moyamoya syndrome secondary to systemic diseases such as&#xD;
             arteriosclerosis, sickle cell anemia, radiation therapy, etc.;&#xD;
&#xD;
          -  Patients with severe mental disorders such as psychosis, liver and kidney dysfunction,&#xD;
             poor blood pressure or blood glucose control, severe depression and substance abuse,&#xD;
             low IQ, and acute phase of severe stroke with definite limb dysfunction should also be&#xD;
             excluded.&#xD;
&#xD;
          -  Pregnancy&#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_official>
    <last_name>Xin Lou, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liu-xian Wang, MM</last_name>
    <phone>+86-18700916575</phone>
    <email>wang_1218@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liu-xian Wang, MM</last_name>
      <phone>+86-18700916575</phone>
      <email>wang_1218@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Xin Lou</investigator_full_name>
    <investigator_title>Deputy Director of Department of Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moyamoya Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 26, 2021</submitted>
    <returned>May 14, 2021</returned>
  </pending_results>
  <!-- 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/NCT03785171
org study id: Multimodal MRI-Moyamoya
nct id: NCT03785171
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by
      a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and
      their proximal branches, with subsequent formation of collateral vessels ("puff of smoke").
      In some cases, the posterior circulation can also be involved. MMD has been discovered around
      the world, but Asians carry the most possibility to develop this disease. Current treatment
      designed to prevent strokes by improving blood flow to the affected cerebral hemisphere
      including medical therapy and surgery. In particular, surgery included two general methods:
      direct and indirect revascularization. Compared with direct bypass, indirect procedures are
      more technically accessible and may reduce the possibility of complications, such as
      hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have
      shown great potential in evaluating perfusion in patients, and could possibly predict
      surgical outcome. However, there is still lack of evidence of the predictive value of MRI in
      evaluating clinical and angiography improvement in patients with MMD.
Imaging protocols:

      3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST

      Imaging evaluation:

        1. Transfer contrast volume value measured by DCE;

        2. ASL shows CBF in associated regions;

        3. Stoke area measured by DWI and Flair;

        4. PH values reflected by APT-CEST.

      Treatment:

      Surgery-indirect revascularization

      Follow-up:

      Baseline (MRI+DSA); 3-months follow-up (MRI); 6-months follow-up (MRI+DSA)
observational model: Case-Only
time perspective: Prospective
measure: Patients selection/stratification
time frame: Three months to 6 months
description: Finding the effect of imaging biomarkers/patterns to provide therapy decision support
measure: Surgical outcome
time frame: Three months to 6 months
description: Finding the effect of imaging biomarkers/patterns to reflect modified Rankin scale
measure: Surgical response
time frame: Three months to 6 months
description: Finding the effect of imaging biomarkers/patterns to reflect revascularized blood flow
arm group label: Moyamoya disease
description: The cohort includes patients with Moyamoya disease diagnosed by DSA examination who are treated by surgical revascularization.
intervention type: Procedure
intervention name: surgical revascularization
description: Indirect revascularization procedure
arm group label: Moyamoya disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xin Lou, MD
role: Study Chair
affiliation: Chinese PLA General Hospital
last name: Liu-xian Wang, MM
phone: +86-18700916575
email: wang_1218@outlook.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Xin Lou
investigator title: Deputy Director of Department of Radiology
mesh term: Moyamoya Disease
sharing ipd: Undecided
submitted: April 26, 2021
returned: May 14, 2021