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/NCT06033963</url>
    </required_header>
    <id_info>
      <org_study_id>SERIC-CASCEA</org_study_id>
      <nct_id>NCT06033963</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy</brief_title>
    <acronym>SERIC-CASCEA</acronym>
    <official_title>Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy: A Pilot, Randomized Controlled Trial</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 explore the safety and efficacy of remote ischemic&#xD;
        conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are&#xD;
        included in our center in China according to the principle of random, and parallel control.&#xD;
        The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg,&#xD;
        2 times per day for 6 consecutive days. The control group receive basic treatment and remote&#xD;
        ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups&#xD;
        will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic&#xD;
        conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.</measure>
      <time_frame>6 days</time_frame>
      <description>Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.</measure>
      <time_frame>6 days</time_frame>
      <description>Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.</measure>
      <time_frame>6 days</time_frame>
      <description>Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with cerebrovascular events, cardiovascular events or death.</measure>
      <time_frame>90±7 days</time_frame>
      <description>Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.</measure>
      <time_frame>6 days</time_frame>
      <description>The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Carotid Artery Stenosis</condition>
    <arm_group>
      <arm_group_label>RIC+CEA+Standard medical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham RIC+CEA+Standard medical treatment</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Remote ischemic conditioning</intervention_name>
      <description>Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.</description>
      <arm_group_label>RIC+CEA+Standard medical treatment</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 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.</description>
      <arm_group_label>Sham RIC+CEA+Standard medical treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age≥18 years, &lt;80 years, regardless of sex;&#xD;
  &#xD;
            2. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the&#xD;
               degree of stenosis should more than 50% (Based on North American Symptomatic Carotid&#xD;
               Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the&#xD;
               degree of stenosis should more than 70% (Based on NASCET Criteria);&#xD;
  &#xD;
            3. Baseline mRS 0-2;&#xD;
  &#xD;
            4. Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;&#xD;
  &#xD;
            5. Signed and dated informed consent is obtained;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Evolving stroke;&#xD;
  &#xD;
            2. Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral&#xD;
               ischemia;&#xD;
  &#xD;
            3. Severe dementia;&#xD;
  &#xD;
            4. The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis,&#xD;
               artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome,&#xD;
               left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart&#xD;
               failure, bacterial endocarditis, etc;&#xD;
  &#xD;
            5. Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic&#xD;
               blood pressure ≥ 110 mmHg, despite medication taken at enrollment);&#xD;
  &#xD;
            6. Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or&#xD;
               alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal&#xD;
               range, creatinine &gt;265umol/l (3mg/dl));&#xD;
  &#xD;
            7. The patients who have the contraindication of remote ischemic conditioning treatment,&#xD;
               such as severe soft tissue injury, fracture or vascular injury in the upper limb.&#xD;
               Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal&#xD;
               syndrome, etc;&#xD;
  &#xD;
            8. Pregnant or lactating women;&#xD;
  &#xD;
            9. He/She is participating in other clinical research or has participated in other&#xD;
               clinical research or has participated in this study within 3 months prior to&#xD;
               admission;&#xD;
  &#xD;
           10. Other conditions that the researchers think are not suitable for the group.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yi Yang, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Neuroscience Center, Department of Neurology, The First Hospital of Jilin University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yi Yang, MD, PhD</last_name>
      <phone>0086-13756661217</phone>
      <email>doctor_yangyi@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhenni Guo, MD, PhD</last_name>
      <email>zhen1ni2@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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 First Hospital of Jilin University</investigator_title>
    </responsible_party>
    <keyword>Remote ischemic conditioning</keyword>
    <keyword>Carotid artery stenosis</keyword>
    <keyword>Carotid endarterectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carotid Stenosis</mesh_term>
      <mesh_term>Constriction, Pathologic</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/NCT06033963
  org study id: SERIC-CASCEA
  nct id: NCT06033963
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to explore the safety and efficacy of remote ischemic
        conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.
  In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are
        included in our center in China according to the principle of random, and parallel control.
        The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg,
        2 times per day for 6 consecutive days. The control group receive basic treatment and remote
        ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups
        will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic
        conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
  time frame: 6 days
  description: Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
  measure: The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
  time frame: 6 days
  description: Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
  measure: The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
  time frame: 6 days
  description: Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.
  measure: Number of patients with cerebrovascular events, cardiovascular events or death.
  time frame: 90±7 days
  description: Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
  measure: Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.
  time frame: 6 days
  description: The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).
  arm group label: RIC+CEA+Standard medical treatment
  arm group type: Active Comparator
  description: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.
  arm group label: Sham RIC+CEA+Standard medical treatment
  arm group type: Placebo Comparator
  description: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. Additionally, the patients will be treated with carotid endarterectomy (CEA) and standard medical treatment according to the Chinese guideline for the secondary prevention of ischemic stroke and transient ischemic attack 2022.
  intervention type: Procedure
  intervention name: Remote ischemic conditioning
  description: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
  arm group label: RIC+CEA+Standard medical treatment
  intervention type: Procedure
  intervention name: Sham remote ischemic conditioning
  description: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.
  arm group label: Sham RIC+CEA+Standard medical treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yi Yang, MD, PhD
  role: Study Chair
  affiliation: Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
  last name: Yi Yang, MD, PhD
  phone: 0086-13756661217
  email: doctor_yangyi@163.com
  last name: Zhenni Guo, MD, PhD
  email: zhen1ni2@163.com
  facility: 
  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 First Hospital of Jilin University
  mesh term: Carotid Stenosis
  mesh term: Constriction, Pathologic