<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/NCT03231384</url>
  </required_header>
  <id_info>
    <org_study_id>RIC/rtPA</org_study_id>
    <nct_id>NCT03231384</nct_id>
  </id_info>
  <brief_title>Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke</brief_title>
  <official_title>Safety and Feasibility of Rt-PA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke(rtPA-RIC1)</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>
    <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 safety and feasibility of remote limb ischemic&#xD;
      conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">February 14, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of RIC after acute ischemic stroke</measure>
    <time_frame>7 days</time_frame>
    <description>The proportion of enrolled subjects that completed all the designed RIC procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective signs of tissue or neurovascular injury</measure>
    <time_frame>within 7(±24h) days</time_frame>
    <description>objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with intracranial hemorrhage in two groups</measure>
    <time_frame>7(±24h)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores assessed by National Institutes of Health Stroke Scale(NIHSS)</measure>
    <time_frame>7(±24h)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The functional outcome at 90 days assessed by modified Rankin scale (mRS).</measure>
    <time_frame>90( ±7days) days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional outcome assessed by Barthel Index(BI)</measure>
    <time_frame>90( ±7days)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral infarct volume.</measure>
    <time_frame>3-7 days after stroke onset</time_frame>
    <description>The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral infarct volume.</measure>
    <time_frame>3-7 days after stroke onset</time_frame>
    <description>The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular parameters during 7 days of RIC treatment.</measure>
    <time_frame>7 days</time_frame>
    <description>the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the heart rate during 7 days of RIC treatment.</measure>
    <time_frame>7 days</time_frame>
    <description>the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of plasma myoglobin</measure>
    <time_frame>baseline and 7(±2)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of serum IL-6</measure>
    <time_frame>baseline and 7(±2)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of serum HS-CRP</measure>
    <time_frame>baseline and 7(±2)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of serum HCY</measure>
    <time_frame>baseline and 7(±2)days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any adverse events</measure>
    <time_frame>90(±7)days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>RIC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The upper limb ischemic conditioning is composed of five cycles of 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 2 hours after r-tPA thrombolytic therapy. 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 received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote 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.&#xD;
Doctormate, IPC-906</description>
    <arm_group_label>RIC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age≥18;&#xD;
&#xD;
          -  Acute ischemic stroke;&#xD;
&#xD;
          -  modified Rankin Scale (mRS) score of 2-5;&#xD;
&#xD;
          -  mRS score less than 1 before onset of stroke symptom;&#xD;
&#xD;
          -  Onset of stroke symptoms within 4.5h before initiation of intravenous rt-PA&#xD;
             thrombolytic therapy;&#xD;
&#xD;
          -  Good compliance for Remote Ischemic Conditioning(RIC) therapy;&#xD;
&#xD;
          -  Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke or serious head trauma within the previous 3 months&#xD;
&#xD;
          -  Major surgery or severe trauma with in the preceding 3 months&#xD;
&#xD;
          -  Intracranial hemorrhage&#xD;
&#xD;
          -  Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg,&#xD;
             or aggressive treatment intravenous medication) necessary to reduce blood pressure to&#xD;
             these limits&#xD;
&#xD;
          -  Symptoms rapidly improving&#xD;
&#xD;
          -  Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal&#xD;
&#xD;
          -  Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days&#xD;
&#xD;
          -  Arterial puncture at a noncompressible site within the previous 7 days&#xD;
&#xD;
          -  Seizure at the onset of stroke&#xD;
&#xD;
          -  Platelet count of less than 100,000 per cubic millimeter&#xD;
&#xD;
          -  Received heparin within the 48 hours preceding the onset of stroke and had an elevated&#xD;
             partial-thromboplastin time&#xD;
&#xD;
          -  Received oral anticoagulation therapy preceding the onset of stroke and INR greater&#xD;
             than 1.7 or prothrombin times greater than 15 seconds&#xD;
&#xD;
          -  CT showed a multiple infarction (low density area greater than 1/3 cerebral&#xD;
             hemisphere)&#xD;
&#xD;
          -  Use or plan to use intervention for diagnosis or treating&#xD;
&#xD;
          -  Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation&#xD;
&#xD;
          -  severe hepatic or renal dysfunction&#xD;
&#xD;
          -  Contraindication for remote ischemic conditioning: severe soft tissue injury,&#xD;
             fracture, or peripheral vascular disease in the upper limbs.&#xD;
&#xD;
          -  Life expectancy&lt;1 years&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Unwilling to be followed up or poor compliance for treatment&#xD;
&#xD;
          -  Patients being enrolled or having been enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>XI Cheng District</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>March 24, 2018</last_update_submitted>
  <last_update_submitted_qc>March 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</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</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</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/NCT03231384
org study id: RIC/rtPA
nct id: NCT03231384
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the safety and feasibility of remote limb ischemic
      conditioning(RIC) in acute ischemic stroke patients who received r-tPA thrombolytic therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility of RIC after acute ischemic stroke
time frame: 7 days
description: The proportion of enrolled subjects that completed all the designed RIC procedures.
measure: Objective signs of tissue or neurovascular injury
time frame: within 7(±24h) days
description: objective signs of tissue or neurovascular injury felt to be due to cuff inflation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
measure: Number of participants with intracranial hemorrhage in two groups
time frame: 7(±24h)days
measure: Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
time frame: 7(±24h)days
measure: The functional outcome at 90 days assessed by modified Rankin scale (mRS).
time frame: 90( ±7days) days
measure: functional outcome assessed by Barthel Index(BI)
time frame: 90( ±7days)days
measure: cerebral infarct volume.
time frame: 3-7 days after stroke onset
description: The infarct volume of cerebral infarct is evaluated by cranial noncontrast MRI
measure: cerebral infarct volume.
time frame: 3-7 days after stroke onset
description: The infarct volume of cerebral infarct is evaluated by cranial noncontrast CT
measure: Cardiovascular parameters during 7 days of RIC treatment.
time frame: 7 days
description: the blood pressure were measured immediately before RIC and also be measured 5 minutes after RIC.
measure: the heart rate during 7 days of RIC treatment.
time frame: 7 days
description: the heart rate were measured immediately before RIC and also be measured 5 minutes after RIC.
measure: Levels of plasma myoglobin
time frame: baseline and 7(±2)days
measure: Levels of serum IL-6
time frame: baseline and 7(±2)days
measure: Levels of serum HS-CRP
time frame: baseline and 7(±2)days
measure: Levels of serum HCY
time frame: baseline and 7(±2)days
measure: Any adverse events
time frame: 90(±7)days
arm group label: RIC group
arm group type: Experimental
description: The upper limb ischemic conditioning is composed of five cycles of 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 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy.
arm group label: Control group
arm group type: No Intervention
description: The participants received r-tPA thrombolytic therapy after diagnosed ischemic stroke. In addition, all participants receive a standard clinical therapy.
intervention type: Device
intervention name: Remote 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.
Doctormate, IPC-906
arm group label: RIC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia