<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/NCT04470492</url>
  </required_header>
  <id_info>
    <org_study_id>RICO</org_study_id>
    <nct_id>NCT04470492</nct_id>
  </id_info>
  <brief_title>Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning</brief_title>
  <official_title>Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ji Xunming,MD,PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical 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 primary objective of the study will be to determine whether remote limb ischemic&#xD;
      conditioning (RLIC) together with conventional medication therapy compared with only&#xD;
      medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in&#xD;
      patients with a recent TIA or IS caused by occlusion of a cerebral artery.&#xD;
&#xD;
      After screening period, eligible patients will be randomly allocated into 2 groups.In&#xD;
      addition, all participants receive an usual clinical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic&#xD;
      Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients&#xD;
      in the control group will be treated only with conventional medication. In the study, the&#xD;
      RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and&#xD;
      reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and&#xD;
      inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-month composite cardio-cerebral vascular event rate</measure>
    <time_frame>During the first 3 months from randomization.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months</measure>
    <time_frame>During the first 3 months from randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months</measure>
    <time_frame>During the first 3 months from randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in modified Rankin Scale(mRS) within 3 months</measure>
    <time_frame>During the first 3 months from randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Barthel Index(BI) within 3 months</measure>
    <time_frame>During the first 3 months from randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month composite cardio-cerebral vascular event rate</measure>
    <time_frame>During the first 12 months from randomization.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Cerebral Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Experiment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Doctormate®+Medical Management</intervention_name>
    <description>Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.</description>
    <arm_group_label>Experiment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Management</intervention_name>
    <description>Patients will be treated with conventional medication for 3 months.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female with age from 40 to 80 years old.&#xD;
&#xD;
          2. Patients with cerebral arterial occlusion which have been confirmed by CTA, MRA, or&#xD;
             other evidence (including intracranial and extracranial arterial occlusion), and there&#xD;
             is no indication of intervention and surgery, and at the same time the patients&#xD;
             combined more than two risk factors for atherosclerosis.&#xD;
&#xD;
          3. The entry event is acute ischemic cerebrovascular disease (TIA or cerebral&#xD;
             infarction), of which the condition was relatively stable within 30 days of onset, and&#xD;
             mRS≤4.&#xD;
&#xD;
          4. 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. Intracranial arterial occlusion due to arterial dissection, Moya Moya disease; any&#xD;
             known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy;&#xD;
             neurosyphilis; any other intracranial infection; any intracranial stenosis associated&#xD;
             with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy;&#xD;
             fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of&#xD;
             central nervous system; post-partum angiopathy; suspected vasospastic process,&#xD;
             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 abnormal laboratory parameters: aspartate transaminase (AST) and/or&#xD;
             alanine transaminase (ALT) &gt;3×upper limit of normal range; creatinine clearance &lt;0.6&#xD;
             ml/s and/or serum creatinine &gt;265 μmol/l (&gt;3.0 mg/dl); 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. Extracranial stenosis ≥50%.&#xD;
&#xD;
         14. 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;
         15. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within&#xD;
             previous 30 days or scheduled in the 12 months after enrollment.&#xD;
&#xD;
         16. Contraindication for remote ischemic conditioning: severe soft tissue injury,&#xD;
             fracture, or peripheral vascular disease in the upper limbs.&#xD;
&#xD;
         17. Life expectancy&lt;3 years.&#xD;
&#xD;
         18. Pregnant or breast-feeding women.&#xD;
&#xD;
         19. Unwilling to be followed up or poor compliance for treatment.&#xD;
&#xD;
         20. Patients being enrolled or having been enrolled in other clinical trial within 3&#xD;
             months prior to this clinical trial.&#xD;
&#xD;
         21. Patients unsuitable for enrollment in the clinical trial according to investigators&#xD;
             decision making.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 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>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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,MD,PhD</investigator_full_name>
    <investigator_title>VP, Professor</investigator_title>
  </responsible_party>
  <keyword>cerebral atherosclerotic occlusion</keyword>
  <keyword>remote ischemic conditioning</keyword>
  <keyword>ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Arteriosclerosis</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04470492
org study id: RICO
nct id: NCT04470492
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study will be to determine whether remote limb ischemic
      conditioning (RLIC) together with conventional medication therapy compared with only
      medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in
      patients with a recent TIA or IS caused by occlusion of a cerebral artery.

      After screening period, eligible patients will be randomly allocated into 2 groups.In
      addition, all participants receive an usual clinical therapy.
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic
      Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients
      in the control group will be treated only with conventional medication. In the study, the
      RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and
      reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and
      inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 3-month composite cardio-cerebral vascular event rate
time frame: During the first 3 months from randomization.
measure: Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
time frame: During the first 3 months from randomization.
measure: Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
time frame: During the first 3 months from randomization.
measure: Changes in modified Rankin Scale(mRS) within 3 months
time frame: During the first 3 months from randomization.
measure: Changes in Barthel Index(BI) within 3 months
time frame: During the first 3 months from randomization.
measure: 12-month composite cardio-cerebral vascular event rate
time frame: During the first 12 months from randomization.
arm group label: Experiment
arm group type: Experimental
arm group label: Control
arm group type: Other
intervention type: Combination Product
intervention name: Doctormate®+Medical Management
description: Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.
arm group label: Experiment
intervention type: Drug
intervention name: Medical Management
description: Patients will be treated with conventional medication for 3 months.
arm group label: Control
criteria: 
gender: All
minimum age: 40 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,MD,PhD
investigator title: VP, Professor
mesh term: Intracranial Arteriosclerosis
mesh term: Atherosclerosis
sharing ipd: Undecided