<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/NCT02971462</url>
  </required_header>
  <id_info>
    <org_study_id>RIC-SVAS</org_study_id>
    <nct_id>NCT02971462</nct_id>
  </id_info>
  <brief_title>Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ji Xunming</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would&#xD;
      reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of&#xD;
      atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of ischemic cerebrovascular events with vertebrobasilar responsibility</measure>
    <time_frame>0-6 months from randomization</time_frame>
    <description>ischemic cerebrovascular events include ischemic stroke and transient ischemic attack</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of composite outcomes events</measure>
    <time_frame>0-6 months from randomization</time_frame>
    <description>composite outcomes events include Number of ischemic stroke ，transient ischemic attack ，cerebral hemorrhage and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events that are related to treatment</measure>
    <time_frame>0-6 months from randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with mRS 0-1</measure>
    <time_frame>0-6 months from randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of hemodynamics</measure>
    <time_frame>0-6 months from randomization</time_frame>
    <description>hemodynamics evaluation by transcranial doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of plasma biomarkers</measure>
    <time_frame>baseline，3 and 6 months</time_frame>
    <description>changes of plasma VEGF and index of thromboelastogramat at the baseline，in the first 3 and 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Vertebrobasilar Ischemia</condition>
  <arm_group>
    <arm_group_label>RIC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants receive a standard clinical therapy after diagnosed ischemic stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ischemic conditioning</intervention_name>
    <description>In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.</description>
    <arm_group_label>RIC group</arm_group_label>
    <other_name>Doctormate, IPC-906</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female with age from 18 to 80 years old.&#xD;
&#xD;
          -  Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior&#xD;
             to randomization.&#xD;
&#xD;
          -  The entry event is attributed to symptomatic atherosclerotic lesion（stenosis is&#xD;
             greater than or equal to 50% or occlusion）in vertebrobasilar artery that is documented&#xD;
             by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).&#xD;
&#xD;
          -  Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Thrombolytic therapy within 24 hours prior to enrollment.&#xD;
&#xD;
          2. Progressive neurological signs within 24 hours prior to enrollment.&#xD;
&#xD;
          3. Cerebral venous thrombosis/stenosis.&#xD;
&#xD;
          4. vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known&#xD;
             vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy;&#xD;
             neurosyphilis; any other infection; any artery stenosis associated with cerebrospinal&#xD;
             fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia;&#xD;
             sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system;&#xD;
             post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.&#xD;
&#xD;
          5. Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or&#xD;
             aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick&#xD;
             sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural&#xD;
             thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or&#xD;
             any other cardiovascular condition interfering with the participation.&#xD;
&#xD;
          6. Uncontrolled severe hypertension [sitting systolic blood pressure (SBP) &gt;180 mmHg&#xD;
             and/or sitting diastolic blood pressure (DBP) &gt;110 mmHg after medication].&#xD;
&#xD;
          7. Patients with serious complications or abnormal laboratory parameters: aspartate&#xD;
             transaminase (AST) and/or alanine transaminase (ALT) &gt;3×upper limit of normal range;&#xD;
             creatinine clearance &lt;0.6 ml/s and/or serum creatinine &gt;265 μmol/l (&gt;3.0 mg/dl);&#xD;
             platelets &lt;100×109/L.&#xD;
&#xD;
          8. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90&#xD;
             days prior to enrollment.&#xD;
&#xD;
          9. Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.&#xD;
&#xD;
         10. Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.&#xD;
&#xD;
         11. Severe hemostatic disorder or severe coagulation dysfunction.&#xD;
&#xD;
         12. Subclavian arterial stenosis≥50% or subclavian steal syndrome.&#xD;
&#xD;
         13. Previous treatment of target lesion with a stent, angioplasty, or other mechanical&#xD;
             device, or plan to perform one of these procedures within 12 months after enrollment.&#xD;
&#xD;
         14. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within&#xD;
             previous 30 days or scheduled in the 6 months after enrollment.&#xD;
&#xD;
         15. Contraindication for remote ischemic conditioning: severe soft tissue injury,&#xD;
             fracture, or peripheral vascular disease in the upper limbs.&#xD;
&#xD;
         16. Pregnant or breast-feeding women.&#xD;
&#xD;
         17. Unwilling to be followed up or poor compliance for treatment.&#xD;
&#xD;
         18. Patients being enrolled or having been enrolled in other clinical trial within 3&#xD;
             months prior to this clinical trial.&#xD;
&#xD;
         19. Patients unsuitable for enrollment in the clinical trial according to investigators&#xD;
             decision making.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xunming Ji, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xunming Ji, MD. PhD</last_name>
    <phone>+86-10-83198952</phone>
    <email>jixunming@vip.163.com</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 19, 2016</last_update_submitted>
  <last_update_submitted_qc>November 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Ji Xunming</investigator_full_name>
    <investigator_title>VP,Professor</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>Vertebrobasilar atherosclerosis</keyword>
  <keyword>remote ischemic conditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertebrobasilar Insufficiency</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Ischemia</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/NCT02971462
org study id: RIC-SVAS
nct id: NCT02971462
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would
      reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of
      atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: number of ischemic cerebrovascular events with vertebrobasilar responsibility
time frame: 0-6 months from randomization
description: ischemic cerebrovascular events include ischemic stroke and transient ischemic attack
measure: number of composite outcomes events
time frame: 0-6 months from randomization
description: composite outcomes events include Number of ischemic stroke ，transient ischemic attack ，cerebral hemorrhage and mortality
measure: Number of participants with adverse events that are related to treatment
time frame: 0-6 months from randomization
measure: number of participants with mRS 0-1
time frame: 0-6 months from randomization
measure: changes of hemodynamics
time frame: 0-6 months from randomization
description: hemodynamics evaluation by transcranial doppler
measure: changes of plasma biomarkers
time frame: baseline，3 and 6 months
description: changes of plasma VEGF and index of thromboelastogramat at the baseline，in the first 3 and 6 months
arm group label: RIC group
arm group type: Experimental
description: Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.
arm group label: Control group
arm group type: No Intervention
description: The participants receive a standard clinical therapy after diagnosed ischemic stroke.
intervention type: Device
intervention name: ischemic conditioning
description: In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
arm group label: RIC group
other name: Doctormate, IPC-906
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xunming Ji, MD. PhD
role: Principal Investigator
affiliation: Xuanwu Hospital, Beijing
last name: Xunming Ji, MD. PhD
phone: +86-10-83198952
email: jixunming@vip.163.com
responsible party type: Sponsor-Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: VP,Professor
mesh term: Vertebrobasilar Insufficiency
mesh term: Atherosclerosis
mesh term: Ischemia