xml: <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/NCT05970653</url>
    </required_header>
    <id_info>
      <org_study_id>RICCA-CSI</org_study_id>
      <nct_id>NCT05970653</nct_id>
    </id_info>
    <brief_title>Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation</brief_title>
    <official_title>Effect of Remote Ischemic Conditioning on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yi Yang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Hospital of Jilin University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of this study is to determine the effect of remote ischemic conditioning on&#xD;
        cerebral autoregulation in patients undergoing cerebrovascular stent implantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled&#xD;
        in the First Hospital of Jilin University, and they will be divided into the RIC group and&#xD;
        the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times&#xD;
        per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received&#xD;
        remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from&#xD;
        enrollment to discharge. Two groups will be followed up to evaluate the effect of remote&#xD;
        ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent&#xD;
        implantation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral autoregulation parameter</measure>
      <time_frame>0-7 days</time_frame>
      <description>Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Remote Ischemic Conditioning</condition>
    <arm_group>
      <arm_group_label>RIC Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham-RIC Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Remote ischemic conditioning</intervention_name>
      <description>Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.</description>
      <arm_group_label>RIC Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Sham remote ischemic conditioning</intervention_name>
      <description>Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.</description>
      <arm_group_label>Sham-RIC Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age≥18 years, regardless of sex;&#xD;
  &#xD;
            -  Patients with symptomatic or asymptomatic cerebral vascular stenosis (including&#xD;
               internal carotid artery system and vertebrobasilar system) who are candidates for&#xD;
               elective cerebrovascular stenting.&#xD;
  &#xD;
            -  Patients or their immediate family members are able and willing to sign informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with progressive stroke;&#xD;
  &#xD;
            -  mRS≥ 2 points before admission;&#xD;
  &#xD;
            -  Patients with other surgical treatments;&#xD;
  &#xD;
            -  Patients with other serious diseases or a life expectancy of less than 3 months&#xD;
  &#xD;
            -  Patients who had contraindication of remote ischemic conditioning, such as severe soft&#xD;
               tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis&#xD;
               in the acute or subacute stage of upper extremities;&#xD;
  &#xD;
            -  Laboratory test indicators are unqualified: aspartate aminotransferase or alanine&#xD;
               aminotransferase is 3 times higher than the upper limit of the normal range, blood&#xD;
               creatinine &gt; 265umol/L (&gt;3mg/dl), platelet &lt; 100×109/L, international normalized ratio&#xD;
               (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) exceed the&#xD;
               upper limit of the normal range;&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  Patients who are participating in other clinical studies, or who have participated in&#xD;
               other clinical studies within 3 months prior to enrollment;&#xD;
  &#xD;
            -  Unwillingness to be followed up or poor adherence to treatment;&#xD;
  &#xD;
            -  Other circumstances that the investigator considers unsuitable for enrolment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yi Yang</last_name>
      <phone>0086-13756661217</phone>
      <email>doctor_yangyi@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhenni Guo</last_name>
      <email>zhen1ni2@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yi Yang, MD, PhD</last_name>
        <phone>18186870008</phone>
        <phone_ext>0086</phone_ext>
        <email>doctoryangyi@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Zhenni Guo, MD, PhD</last_name>
        <phone>18186872986</phone>
        <phone_ext>0086</phone_ext>
        <email>zhen1ni2@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
      <investigator_full_name>Yi Yang</investigator_full_name>
      <investigator_title>Associated Dean of The First Hospital of Jilin University</investigator_title>
    </responsible_party>
    <keyword>Remote Ischemic Conditioning</keyword>
    <keyword>Cerebrovascular Stent Implantation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970653
  org study id: RICCA-CSI
  nct id: NCT05970653
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine the effect of remote ischemic conditioning on
        cerebral autoregulation in patients undergoing cerebrovascular stent implantation.
  In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled
        in the First Hospital of Jilin University, and they will be divided into the RIC group and
        the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times
        per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received
        remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from
        enrollment to discharge. Two groups will be followed up to evaluate the effect of remote
        ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent
        implantation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Cerebral autoregulation parameter
  time frame: 0-7 days
  description: Cerebral autoregulation parameters derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameter.
  arm group label: RIC Group
  arm group type: Active Comparator
  description: Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.
  arm group label: Sham-RIC Group
  arm group type: Placebo Comparator
  description: Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days or from enrollment to discharge.
  intervention type: Procedure
  intervention name: Remote ischemic conditioning
  description: Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
  arm group label: RIC Group
  intervention type: Procedure
  intervention name: Sham remote ischemic conditioning
  description: Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
  arm group label: Sham-RIC Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yi Yang
  phone: 0086-13756661217
  email: doctor_yangyi@163.com
  last name: Zhenni Guo
  email: zhen1ni2@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: The First Hospital of Jilin University
  investigator full name: Yi Yang
  investigator title: Associated Dean of The First Hospital of Jilin University
  mesh term: Ischemia