<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/NCT03821181</url>
  </required_header>
  <id_info>
    <org_study_id>RIC-PMD-1</org_study_id>
    <nct_id>NCT03821181</nct_id>
  </id_info>
  <brief_title>The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease</brief_title>
  <acronym>RIC-PMD-1</acronym>
  <official_title>Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>307 Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Capital Medical University</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>
      Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in&#xD;
      children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in&#xD;
      intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in&#xD;
      children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke&#xD;
      in children with moyamoya disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will provide insights into the preliminary proof of principle, safety, and&#xD;
      efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future&#xD;
      larger scale clinical trials if efficacious&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 8, 2019</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence rate of transient ischemic attack(TIA)</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence rate of ischemic stroke</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cerebral perfusion</measure>
    <time_frame>change from baseline to 12months after therapy</time_frame>
    <description>cerebral perfusion status in the operation side at 12 months posttreatment as assessed by single photon emission computed tomography (SPECT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean blood flow velocity of cerebral vascular detected by TCCD</measure>
    <time_frame>changes form baseline to 6months，12months after therapy</time_frame>
    <description>TCCD means tran-scranial color-coded duplex sonography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The score of National Institute of Health stroke scale score</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.The NHISS will be assessed by certified study investigator, who is blinded to the treatment assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The score of Modified Rankin scale score</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). The investigators will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of symptomatic intracerebral hemorrhage</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>Symptomatic intracranial hemorrhage, including any subarachnoid hemorrhage associated with clinical symptoms and symptomatic intracerebral hemorrhage. Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of cerebral lacunar infarction</measure>
    <time_frame>changes from baseline to 12months after therapy</time_frame>
    <description>magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volume of cerebral lacunar infarction</measure>
    <time_frame>changes from baseline to 12 months after therapy</time_frame>
    <description>magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of death and adverse event</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>All causes of death will be included to compute mortality at 12 months after therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of distal radial pulses</measure>
    <time_frame>changes from baseline to 6, 12months after therapy</time_frame>
    <description>professional doctors will check the distal radial pulses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual inspection of local edema of fundus oculi</measure>
    <time_frame>changes from baseline to 6, 12months after therapy</time_frame>
    <description>Professional oculists will visually inspect the fundus oculi to evaluate whether there is local edema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with erythema,and/or skin lesions related to RIC</measure>
    <time_frame>changes from baseline to 6, 12months after therapy</time_frame>
    <description>Professional doctors will check it and the investigator will record the number.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palpation for tenderness</measure>
    <time_frame>changes from baseline to 6, 12months after therapy</time_frame>
    <description>Professional doctors will definite whether there's a palpation for tenderness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>The investigator will record the number.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with any other adverse events related to RIC intervention</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>The investigator will record the number.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The score of ABCD2</measure>
    <time_frame>during baseline to 12months after therapy</time_frame>
    <description>When subjects are diagnosed as TIA within 12 months after therapy ,The investigators use this scale to evaluate the patients' risk of stroke who with TIA .The score of the scale ranges from 0 to 7, and the higher score indicates higher risk of stroke in the patients who with TIA.The scale will be assessed by qualified investigator who are blinded to the treatment assignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of S-100A4</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of matrix metalloproteinase 9 (MMP-9)</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of basic fibroblast growth factor</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of platelet derived growth factor</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of vascular endothelial growth factor</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of hs-CRP(high-sensitive C-reactive protein)</measure>
    <time_frame>change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy</time_frame>
    <description>Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral perfusion examined by SPECT</measure>
    <time_frame>from baseline（pre-RIC treatment) to 12 months after therapy</time_frame>
    <description>cerebral perfusion status post-treatment will be assessed by single photon emission computed tomography (SPECT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral perfusion examined by ASL</measure>
    <time_frame>from baseline（pre-RIC treatment) to 12 months after therapy</time_frame>
    <description>cerebral perfusion status post-treatment will be assessed by arterial spin labeling(ASL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variant of the RNF-213 gene</measure>
    <time_frame>from baseline（pre-RIC treatment) to 12 months after therapy</time_frame>
    <description>The investigators will save the blood sample in -20℃，and detect the variant RNF-213 gene</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Moyamoya Disease</condition>
  <condition>TIA</condition>
  <condition>Children</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>RIC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RIC group</intervention_name>
    <description>Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.</description>
    <arm_group_label>RIC group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham group</intervention_name>
    <description>patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.</description>
    <arm_group_label>sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: ≥0 and ≤18&#xD;
&#xD;
          -  all of the patients underwent digital subtraction angiography and met the current&#xD;
             diagnostic criteria recommended by the Research Committee on MMD (Spontaneous&#xD;
             Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in&#xD;
             2012&#xD;
&#xD;
          -  The CVR of patients detected by SPECT is not impaired severely&#xD;
&#xD;
          -  The patients didn't suffer stroke before.&#xD;
&#xD;
          -  Informed consent obtained from patient or acceptable patient's surrogate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hepatic or renal dysfunction&#xD;
&#xD;
          -  Severe hemostatic disorder or severe coagulation dysfunction&#xD;
&#xD;
          -  Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused&#xD;
             by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or&#xD;
             previous skull-base radiation therapy&#xD;
&#xD;
          -  Any of the following cardiac disease - rheumatic mitral and or aortic stenosis,&#xD;
             prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome,&#xD;
             left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular&#xD;
             vegetation, congestive heart failure, bacterial endocarditis, or any other&#xD;
             cardiovascular condition interfering with participation&#xD;
&#xD;
          -  Serious, advanced, or terminal illnesses with anticipated life expectancy of less than&#xD;
             one year&#xD;
&#xD;
          -  Patient participating in a study involving other drug or device trial study&#xD;
&#xD;
          -  Patients with existing neurological or psychiatric disease that would confound the&#xD;
             neurological or functional evaluations&#xD;
&#xD;
          -  Unlikely to be available for follow-up for 3 months&#xD;
&#xD;
          -  Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular&#xD;
             disease in the upper limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xunming Ji, MD PhD</last_name>
    <phone>108613911077166</phone>
    <email>Jixunming@vip.163.com;</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sijie Li, MD</last_name>
    <phone>1083199439</phone>
    <email>phoenix0537@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Ji Xunming,MD,PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pediatric moyamoya disease</keyword>
  <keyword>TIA</keyword>
  <keyword>Stroke</keyword>
  <keyword>Remote ischemic conditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Moyamoya Disease</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/NCT03821181
org study id: RIC-PMD-1
nct id: NCT03821181
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in
      children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in
      intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in
      children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke
      in children with moyamoya disease.
This study will provide insights into the preliminary proof of principle, safety, and
      efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future
      larger scale clinical trials if efficacious
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence rate of transient ischemic attack(TIA)
time frame: during baseline to 12months after therapy
description: TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
measure: The incidence rate of ischemic stroke
time frame: during baseline to 12months after therapy
description: Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
measure: Cerebral perfusion
time frame: change from baseline to 12months after therapy
description: cerebral perfusion status in the operation side at 12 months posttreatment as assessed by single photon emission computed tomography (SPECT).
measure: The mean blood flow velocity of cerebral vascular detected by TCCD
time frame: changes form baseline to 6months，12months after therapy
description: TCCD means tran-scranial color-coded duplex sonography.
measure: The score of National Institute of Health stroke scale score
time frame: during baseline to 12months after therapy
description: National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.The NHISS will be assessed by certified study investigator, who is blinded to the treatment assignment.
measure: The score of Modified Rankin scale score
time frame: during baseline to 12months after therapy
description: The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). The investigators will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment.
measure: Incidence rate of symptomatic intracerebral hemorrhage
time frame: during baseline to 12months after therapy
description: Symptomatic intracranial hemorrhage, including any subarachnoid hemorrhage associated with clinical symptoms and symptomatic intracerebral hemorrhage. Head computed tomography or magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
measure: The number of cerebral lacunar infarction
time frame: changes from baseline to 12months after therapy
description: magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
measure: The volume of cerebral lacunar infarction
time frame: changes from baseline to 12 months after therapy
description: magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
measure: The rate of death and adverse event
time frame: during baseline to 12months after therapy
description: All causes of death will be included to compute mortality at 12 months after therapy
measure: Number of distal radial pulses
time frame: changes from baseline to 6, 12months after therapy
description: professional doctors will check the distal radial pulses
measure: Visual inspection of local edema of fundus oculi
time frame: changes from baseline to 6, 12months after therapy
description: Professional oculists will visually inspect the fundus oculi to evaluate whether there is local edema.
measure: The number of patients with erythema,and/or skin lesions related to RIC
time frame: changes from baseline to 6, 12months after therapy
description: Professional doctors will check it and the investigator will record the number.
measure: Palpation for tenderness
time frame: changes from baseline to 6, 12months after therapy
description: Professional doctors will definite whether there's a palpation for tenderness
measure: The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
time frame: during baseline to 12months after therapy
description: The investigator will record the number.
measure: The number of patients with any other adverse events related to RIC intervention
time frame: during baseline to 12months after therapy
description: The investigator will record the number.
measure: The score of ABCD2
time frame: during baseline to 12months after therapy
description: When subjects are diagnosed as TIA within 12 months after therapy ,The investigators use this scale to evaluate the patients' risk of stroke who with TIA .The score of the scale ranges from 0 to 7, and the higher score indicates higher risk of stroke in the patients who with TIA.The scale will be assessed by qualified investigator who are blinded to the treatment assignment.
measure: The level of S-100A4
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: The level of matrix metalloproteinase 9 (MMP-9)
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: The level of basic fibroblast growth factor
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: The level of platelet derived growth factor
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: The level of vascular endothelial growth factor
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: The level of hs-CRP(high-sensitive C-reactive protein)
time frame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
description: Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
measure: cerebral perfusion examined by SPECT
time frame: from baseline（pre-RIC treatment) to 12 months after therapy
description: cerebral perfusion status post-treatment will be assessed by single photon emission computed tomography (SPECT).
measure: cerebral perfusion examined by ASL
time frame: from baseline（pre-RIC treatment) to 12 months after therapy
description: cerebral perfusion status post-treatment will be assessed by arterial spin labeling(ASL)
measure: variant of the RNF-213 gene
time frame: from baseline（pre-RIC treatment) to 12 months after therapy
description: The investigators will save the blood sample in -20℃，and detect the variant RNF-213 gene
arm group label: RIC group
arm group type: Experimental
description: Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
arm group label: sham group
arm group type: Sham Comparator
description: patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
intervention type: Device
intervention name: RIC group
description: Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
arm group label: RIC group
intervention type: Device
intervention name: Sham group
description: patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
arm group label: sham group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Xunming Ji, MD PhD
phone: 108613911077166
email: Jixunming@vip.163.com;
last name: Sijie Li, MD
phone: 1083199439
email: phoenix0537@sina.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming,MD,PhD
investigator title: Professor
mesh term: Stroke
mesh term: Moyamoya Disease