<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/NCT03004820</url>
  </required_header>
  <id_info>
    <org_study_id>RICMIS/TIA</org_study_id>
    <nct_id>NCT03004820</nct_id>
  </id_info>
  <brief_title>Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning</brief_title>
  <acronym>PICNIC-ONE</acronym>
  <official_title>Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study</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>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-arm, open-labeled and phase II futility study. Application of Remote&#xD;
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the&#xD;
      study. The study is to test whether RIC is effective in preventing ischemic evens after a&#xD;
      minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and&#xD;
      compliance of chronic RIC. Medication strategy is based on physician's best judgement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm, open-labeled and phase II futility study. Application of Remote&#xD;
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the&#xD;
      study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff&#xD;
      on bilateral upper limbs twice a day. The study is to test whether RIC is effective in&#xD;
      preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3&#xD;
      months and to explore the safety and compliance of chronic RIC. Medication strategy is based&#xD;
      on physician's best judgement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">October 19, 2017</completion_date>
  <primary_completion_date type="Actual">October 19, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients will receive remote ischemic conditioning</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent rate of ischemic stroke/transient ischemic stroke</measure>
    <time_frame>within 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment-Related Adverse Events</measure>
    <time_frame>within 3 months</time_frame>
    <description>pain and tolerability, redness, bleeding, palpitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance of remote ischemic conditioning</measure>
    <time_frame>within 3 months</time_frame>
    <description>the proportion of patients fulfill the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of vascular events</measure>
    <time_frame>within 3 months</time_frame>
    <description>hemorrhage stroke, myocardial infarction and vascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in NIH Stroke Scale</measure>
    <time_frame>within1, 3 months</time_frame>
    <description>improvements in NIH Stroke Scale in patients without recurrence or vascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in modified Rankin Scale</measure>
    <time_frame>within 1, 3 months</time_frame>
    <description>improvements in modified Rankin Scale Scale in patients without recurrence or vascular events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in Barthel Scale</measure>
    <time_frame>within 1,3 months</time_frame>
    <description>improvements in Barthel Scale in patients without recurrence or vascular events</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months</measure>
    <time_frame>within 1 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Transient Ischemic Attack</condition>
  <condition>Non-disabling Stroke</condition>
  <arm_group>
    <arm_group_label>Remote Ischemic Conditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Remote Ischemic Conditioning</intervention_name>
    <description>RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.</description>
    <arm_group_label>Remote Ischemic Conditioning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eighteen years old or older of any gender or race;&#xD;
&#xD;
          2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic&#xD;
             stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as&#xD;
             neurologic deficit attributed to focal brain ischemia, with symptoms resolution within&#xD;
             24 h of symptom onset, Symptom onset is defined by the &quot;last see normal&quot; principle;&#xD;
&#xD;
          3. Stable vital signs, normal cardiac, hepatic and renal functions;&#xD;
&#xD;
          4. Able to consent by himself/herself or by legally authorized representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor,&#xD;
             abscess or other non-vascular diseases, based on brain CT or MRI;&#xD;
&#xD;
          2. Modified Rankin Scale score &gt; 2 at inclusion;&#xD;
&#xD;
          3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional&#xD;
             treatment for the current event;&#xD;
&#xD;
          4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart&#xD;
             failure et al.) ;&#xD;
&#xD;
          5. Clear indication for anticoagulation therapy ( cardiac source of embolus);&#xD;
&#xD;
          6. Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder,&#xD;
             platelet count &lt;100 × 109/L, history of drug-induced hepatic dysfunction）;&#xD;
&#xD;
          7. Any hemorrhagic transformation;&#xD;
&#xD;
          8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset;&#xD;
&#xD;
          9. Stroke or TIA induced by interventional therapy or surgery;&#xD;
&#xD;
         10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease&#xD;
             which may contraindicate RIC;&#xD;
&#xD;
         11. Systolic blood pressure greater than 200 mmHg after medication;&#xD;
&#xD;
         12. Planned revascularization (any angioplasty or vascular surgery) within the next 3&#xD;
             months ；&#xD;
&#xD;
         13. Scheduled for surgery or interventional treatment requiring RIC cessation within next&#xD;
             3 months;&#xD;
&#xD;
         14. Severe noncardiovascular comorbidity with life expectancy &lt; 3 months;&#xD;
&#xD;
         15. Pregnancy;&#xD;
&#xD;
         16. Currently receiving an investigational drug or device by other studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 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_official>
    <last_name>Wuwei Feng, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <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>
    <facility>
      <name>First Affiliated Hospital of Hainan Medical University</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taoyuan People's Hospital</name>
      <address>
        <city>Changde</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengli Oilfield Center Hospital</name>
      <address>
        <city>Dongying</city>
        <state>Shandong</state>
        <zip>257034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 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, Chief Surgeon, Vice President</investigator_title>
  </responsible_party>
  <keyword>Minor Ischemic Stroke</keyword>
  <keyword>Transient Ischemic Attack</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>Ischemic Attack, Transient</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03004820
org study id: RICMIS/TIA
nct id: NCT03004820
lead sponsor: 
has dmc: Yes
is fda regulated device: No
This is a single-arm, open-labeled and phase II futility study. Application of Remote
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the
      study. The study is to test whether RIC is effective in preventing ischemic evens after a
      minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and
      compliance of chronic RIC. Medication strategy is based on physician's best judgement.
This is a single-arm, open-labeled and phase II futility study. Application of Remote
      ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the
      study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff
      on bilateral upper limbs twice a day. The study is to test whether RIC is effective in
      preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3
      months and to explore the safety and compliance of chronic RIC. Medication strategy is based
      on physician's best judgement.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients will receive remote ischemic conditioning
primary purpose: Prevention
masking: None (Open Label)
measure: Recurrent rate of ischemic stroke/transient ischemic stroke
time frame: within 3 months
measure: Treatment-Related Adverse Events
time frame: within 3 months
description: pain and tolerability, redness, bleeding, palpitation
measure: Compliance of remote ischemic conditioning
time frame: within 3 months
description: the proportion of patients fulfill the treatment
measure: Incidence rate of vascular events
time frame: within 3 months
description: hemorrhage stroke, myocardial infarction and vascular death
measure: Improvements in NIH Stroke Scale
time frame: within1, 3 months
description: improvements in NIH Stroke Scale in patients without recurrence or vascular events
measure: Improvements in modified Rankin Scale
time frame: within 1, 3 months
description: improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
measure: Improvements in Barthel Scale
time frame: within 1,3 months
description: improvements in Barthel Scale in patients without recurrence or vascular events
measure: Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months
time frame: within 1 months
arm group label: Remote Ischemic Conditioning
arm group type: Experimental
description: RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.
intervention type: Device
intervention name: Remote Ischemic Conditioning
description: RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.
arm group label: Remote Ischemic Conditioning
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Xunming Ji, MD, PhD
role: Principal Investigator
affiliation: Xuanwu Hospital, Beijing
last name: Wuwei Feng, MD, MS
role: Study Director
affiliation: Medical University of South Carolina
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: Professor, Chief Surgeon, Vice President
mesh term: Stroke
mesh term: Ischemic Attack, Transient
mesh term: Ischemia
sharing ipd: No