<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/NCT01672515</url>
  </required_header>
  <id_info>
    <org_study_id>2012-RIPC-cerebral infarction</org_study_id>
    <nct_id>NCT01672515</nct_id>
  </id_info>
  <brief_title>Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction</brief_title>
  <official_title>Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is one of the three leading causes of human death, and a major cause of adult&#xD;
      disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent&#xD;
      cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce&#xD;
      infarct size of cerebral infarction. Investigators hypothesized that postconditioning would&#xD;
      reduce infarct volume of ischemic stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study explored the neuroprotective effects of post-positioning on ischemic stroke&#xD;
      patients with randomized, double-blinded and controlled method. Patients are divided into&#xD;
      experimental and placebo groups to receive remote ischemic post-conditioning for 30 days.&#xD;
      Remote ischemic post-conditioning is performed by the inflating tourniquets to certain&#xD;
      extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the&#xD;
      total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group.&#xD;
      Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days&#xD;
      after treatment; and MRI at 0 and 30 days after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">October 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local tissue damage 30 days after RIPC treatment</measure>
    <time_frame>30 days after RIPC treatment</time_frame>
    <description>Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of plasma biomarkers assay right before RIPC treatment</measure>
    <time_frame>right before RIPC treatment (within 24hrs)</time_frame>
    <description>levels of CRP、TINF-α、slCAM-1 and GFAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of plasma biomarkers assay 3 days after RIPC treatment.</measure>
    <time_frame>3 days after RIPC treatment.</time_frame>
    <description>levels of CRP、TINF-α、slCAM-1 and GFAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of plasma biomarkers assay 15 days after RIPC treatment.</measure>
    <time_frame>15 days after RIPC treatment.</time_frame>
    <description>levels of CRP、TINF-α、slCAM-1 and GFAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of plasma biomarkers assay 30 days after RIPC treatment</measure>
    <time_frame>30 days after RIPC treatment</time_frame>
    <description>levels of CRP、TINF-α、slCAM-1 and GFAP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of plasma biomarkers assay right after RIPC treatment</measure>
    <time_frame>right after RIPC treatment (within 24hrs)</time_frame>
    <description>levels of CRP、TINF-α、slCAM-1 and GFAP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infarct volume evaluation before RIPC treatment.</measure>
    <time_frame>Acute phase of ischemic stroke, and before RIPC treatment</time_frame>
    <description>MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct volume after RIPC treatment in ischemic stroke patients</measure>
    <time_frame>30 days after RIPC treatment in ischemic stroke patients</time_frame>
    <description>Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>RIPC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RIPC group</intervention_name>
    <arm_group_label>RIPC group</arm_group_label>
    <other_name>Brand name: Doctormate</other_name>
    <other_name>Type: IPC-906X</other_name>
    <other_name>Productor: Beijing Renqiao Institute of Neuroscience</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control group</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Brand name: Doctormate</other_name>
    <other_name>Type: modified version of IPC-906X</other_name>
    <other_name>Productor: Beijing Renqiao Institute of Neuroscience</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 40 to 80 Years&#xD;
&#xD;
          2. Ischemic cerebrovascular disease within 6 hours&#xD;
&#xD;
          3. National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin&#xD;
             Scale(mRS) score 0-4&#xD;
&#xD;
          4. Cranial CT to rule out the the cerebral hemorrhage&#xD;
&#xD;
          5. Written informed consent was&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cerebral hemorrhage&#xD;
&#xD;
          2. Other parts of the active bleeding disease&#xD;
&#xD;
          3. Atrial fibrillation&#xD;
&#xD;
          4. Moyamoya disease or vasculitis&#xD;
&#xD;
          5. Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy&#xD;
&#xD;
          6. Out coagulation disorder&#xD;
&#xD;
          7. Severe lesions of severe liver and kidney disease, malignancy or other systemic&#xD;
&#xD;
          8. Cannot tolerate BLIPC or without informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2012</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</investigator_full_name>
    <investigator_title>Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT01672515
org study id: 2012-RIPC-cerebral infarction
nct id: NCT01672515
lead sponsor: 
has dmc: Yes
Stroke is one of the three leading causes of human death, and a major cause of adult
      disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent
      cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce
      infarct size of cerebral infarction. Investigators hypothesized that postconditioning would
      reduce infarct volume of ischemic stroke patients.
This study explored the neuroprotective effects of post-positioning on ischemic stroke
      patients with randomized, double-blinded and controlled method. Patients are divided into
      experimental and placebo groups to receive remote ischemic post-conditioning for 30 days.
      Remote ischemic post-conditioning is performed by the inflating tourniquets to certain
      extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the
      total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group.
      Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days
      after treatment; and MRI at 0 and 30 days after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Local tissue damage 30 days after RIPC treatment
time frame: 30 days after RIPC treatment
description: Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage
measure: Levels of plasma biomarkers assay right before RIPC treatment
time frame: right before RIPC treatment (within 24hrs)
description: levels of CRP、TINF-α、slCAM-1 and GFAP
measure: Levels of plasma biomarkers assay 3 days after RIPC treatment.
time frame: 3 days after RIPC treatment.
description: levels of CRP、TINF-α、slCAM-1 and GFAP
measure: Levels of plasma biomarkers assay 15 days after RIPC treatment.
time frame: 15 days after RIPC treatment.
description: levels of CRP、TINF-α、slCAM-1 and GFAP
measure: Levels of plasma biomarkers assay 30 days after RIPC treatment
time frame: 30 days after RIPC treatment
description: levels of CRP、TINF-α、slCAM-1 and GFAP
measure: Levels of plasma biomarkers assay right after RIPC treatment
time frame: right after RIPC treatment (within 24hrs)
description: levels of CRP、TINF-α、slCAM-1 and GFAP
measure: Infarct volume evaluation before RIPC treatment.
time frame: Acute phase of ischemic stroke, and before RIPC treatment
description: MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.
measure: Infarct volume after RIPC treatment in ischemic stroke patients
time frame: 30 days after RIPC treatment in ischemic stroke patients
description: Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment
arm group label: RIPC group
arm group type: Experimental
description: RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
arm group label: Control group
arm group type: Sham Comparator
description: RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.
intervention type: Device
intervention name: RIPC group
arm group label: RIPC group
other name: Brand name: Doctormate
other name: Type: IPC-906X
other name: Productor: Beijing Renqiao Institute of Neuroscience
intervention type: Device
intervention name: Control group
arm group label: Control group
other name: Brand name: Doctormate
other name: Type: modified version of IPC-906X
other name: Productor: Beijing Renqiao Institute of Neuroscience
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University
mesh term: Cerebral Infarction
mesh term: Infarction