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/NCT05982015</url>
    </required_header>
    <id_info>
      <org_study_id>RICA-2</org_study_id>
      <nct_id>NCT05982015</nct_id>
    </id_info>
    <brief_title>Remote Ischemic Conditioning for Stroke-associated Pneumonia</brief_title>
    <acronym>RICA-2</acronym>
    <official_title>The Preventive Effect of Remote Ischemic Conditioning in Reducing Stroke-Associated Pneumonia: an Investigator-initiated, Multicenter, Randomized, Double-blind, Sham-controlled Trial</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_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related&#xD;
        pneumonia in acute stroke patients within 24 hours of onset&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke&#xD;
        related pneumonia in acute stroke patients within 24 hours of onset&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Stroke-associated pneumonia</measure>
      <time_frame>7 days</time_frame>
      <description>Stroke-associated pneumonia incidence rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physician diagnosed pneumonia</measure>
      <time_frame>7 days</time_frame>
      <description>Physician diagnosed pneumonia incidence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physician diagnosed pneumonia</measure>
      <time_frame>8-90 days</time_frame>
      <description>Physician diagnosed pneumonia incidence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin scale 0-1</measure>
      <time_frame>90 days after the onset of symptoms</time_frame>
      <description>defined by 0-1 of the modified Rankin Scale (mRS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin scale 0-2</measure>
      <time_frame>90 days</time_frame>
      <description>defined by 0-2 of the modified Rankin Scale (mRS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin scale</measure>
      <time_frame>90 days</time_frame>
      <description>Shift analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L</measure>
      <time_frame>90 days</time_frame>
      <description>The score of EQ-5D-5L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NIHSS stroke scale</measure>
      <time_frame>24 hours</time_frame>
      <description>The score of NIHSS stroke scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NIHSS stroke scale</measure>
      <time_frame>7 days</time_frame>
      <description>The score of NIHSS stroke scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urinary tract infections</measure>
      <time_frame>7 days</time_frame>
      <description>Urinary tract infections incidence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infections</measure>
      <time_frame>7 days</time_frame>
      <description>Infections incidence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>90 days</time_frame>
      <description>All-cause mortality incidence rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inpatient days</measure>
      <time_frame>90 days</time_frame>
      <description>Total inpatient days</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Spots of skin bleeding within 7 days</measure>
      <time_frame>7 days</time_frame>
      <description>Number of subjects who have skin bleeding points within 7 days</description>
    </other_outcome>
    <other_outcome>
      <measure>Red or swollen arms within 7 days</measure>
      <time_frame>7 days</time_frame>
      <description>Number of subjects who have red or swollen arms within 7 days</description>
    </other_outcome>
    <other_outcome>
      <measure>Dizziness within 7 days</measure>
      <time_frame>7 days</time_frame>
      <description>Number of subjects who have dizziness within 7 days</description>
    </other_outcome>
    <other_outcome>
      <measure>Nausea within 7 days</measure>
      <time_frame>7 days</time_frame>
      <description>Number of subjects who have nausea within 7 days</description>
    </other_outcome>
    <other_outcome>
      <measure>Palpitations within 7 days.</measure>
      <time_frame>7 days</time_frame>
      <description>Number of subjects who have palpitations within 7 days.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1650</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Remote ischemic conditioning (RIC) -200mmHg and best medical management</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Remote ischemic conditioning (RIC) -60mmHg and best medical management</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Remote ischemic conditioning</intervention_name>
      <description>The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham remote ischemic conditioning</intervention_name>
      <description>The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.</description>
      <arm_group_label>Sham group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age≥18 years old;&#xD;
  &#xD;
            -  Diagnosis of acute ischemic stroke;&#xD;
  &#xD;
            -  Remote ischemic conditioning or sham-remote ischemic conditioning can be treated&#xD;
               within 24 hours after stroke onset&#xD;
  &#xD;
            -  NIHSS score≥4;&#xD;
  &#xD;
            -  Subject or his or her legally authorized representative was able to provide informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  During the screening period, body temperature ≥ 38 ℃;&#xD;
  &#xD;
            -  Evidence of lung infection, urinary tract infection or other infectious diseases&#xD;
               during the screening period&#xD;
  &#xD;
            -  Expected lifespan less than 7 days&#xD;
  &#xD;
            -  Mechanical ventilation is expected to be required within 7 days;&#xD;
  &#xD;
            -  Anti-infective drug were used within 7 days prior to stroke;&#xD;
  &#xD;
            -  Uncontrolled hypertension with medication (defined as systolic blood pressure ≥200&#xD;
               mmHg and/or diastolic blood pressure ≥110 mmHg);&#xD;
  &#xD;
            -  There are contraindications for remote ischemic conditioning (such as skin and soft&#xD;
               tissue injury, fractures, peripheral arterial disease, etc. in the upper limbs);&#xD;
  &#xD;
            -  History of autoimmune disease or malignancies;&#xD;
  &#xD;
            -  Use of immunosuppressive drug within the preceding 3 months;&#xD;
  &#xD;
            -  Pregnant or lactating, or pregnancy test positive;&#xD;
  &#xD;
            -  Current participation in another investigational trial;&#xD;
  &#xD;
            -  Other conditions are not suitable for this trial as evaluated by researchers.&#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_official>
      <last_name>Chuanjie Wu, M.D.</last_name>
      <role>Study Director</role>
      <affiliation>Xuanwu Hospital of Capital Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xunming Ji, M.D. Ph.D</last_name>
      <phone>861013120136877</phone>
      <email>jixunming@vip.163.com; 1730812302@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lina Jia, M.D.</last_name>
      <phone>+8615901588600</phone>
      <email>1730812302@qq.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.</citation>
      <PMID>25612858</PMID>
    </reference>
    <reference>
      <citation>Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.</citation>
      <PMID>26343840</PMID>
    </reference>
    <reference>
      <citation>Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.</citation>
      <PMID>27733675</PMID>
    </reference>
    <reference>
      <citation>Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.</citation>
      <PMID>22664787</PMID>
    </reference>
    <reference>
      <citation>Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.</citation>
      <PMID>21738161</PMID>
    </reference>
    <reference>
      <citation>Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.</citation>
      <PMID>17255542</PMID>
    </reference>
    <reference>
      <citation>Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.</citation>
      <PMID>25176179</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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,MD,PhD</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>Pneumonia</mesh_term>
      <mesh_term>Stroke</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/NCT05982015
  org study id: RICA-2
  nct id: NCT05982015
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Verifying whether remote ischemic adaptation can reduce the occurrence of stroke related
        pneumonia in acute stroke patients within 24 hours of onset
  Verifying whether remote ischemic adaptation can reduce the occurrence and safety of stroke
        related pneumonia in acute stroke patients within 24 hours of onset
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Stroke-associated pneumonia
  time frame: 7 days
  description: Stroke-associated pneumonia incidence rate
  measure: Physician diagnosed pneumonia
  time frame: 7 days
  description: Physician diagnosed pneumonia incidence rate
  measure: Physician diagnosed pneumonia
  time frame: 8-90 days
  description: Physician diagnosed pneumonia incidence rate
  measure: Modified Rankin scale 0-1
  time frame: 90 days after the onset of symptoms
  description: defined by 0-1 of the modified Rankin Scale (mRS)
  measure: Modified Rankin scale 0-2
  time frame: 90 days
  description: defined by 0-2 of the modified Rankin Scale (mRS)
  measure: Modified Rankin scale
  time frame: 90 days
  description: Shift analysis
  measure: EQ-5D-5L
  time frame: 90 days
  description: The score of EQ-5D-5L
  measure: NIHSS stroke scale
  time frame: 24 hours
  description: The score of NIHSS stroke scale
  measure: NIHSS stroke scale
  time frame: 7 days
  description: The score of NIHSS stroke scale
  measure: Urinary tract infections
  time frame: 7 days
  description: Urinary tract infections incidence rate
  measure: Infections
  time frame: 7 days
  description: Infections incidence rate
  measure: All-cause mortality
  time frame: 90 days
  description: All-cause mortality incidence rate
  measure: Inpatient days
  time frame: 90 days
  description: Total inpatient days
  measure: Spots of skin bleeding within 7 days
  time frame: 7 days
  description: Number of subjects who have skin bleeding points within 7 days
  measure: Red or swollen arms within 7 days
  time frame: 7 days
  description: Number of subjects who have red or swollen arms within 7 days
  measure: Dizziness within 7 days
  time frame: 7 days
  description: Number of subjects who have dizziness within 7 days
  measure: Nausea within 7 days
  time frame: 7 days
  description: Number of subjects who have nausea within 7 days
  measure: Palpitations within 7 days.
  time frame: 7 days
  description: Number of subjects who have palpitations within 7 days.
  arm group label: Intervention group
  arm group type: Experimental
  description: Remote ischemic conditioning (RIC) -200mmHg and best medical management
  arm group label: Sham group
  arm group type: Sham Comparator
  description: Remote ischemic conditioning (RIC) -60mmHg and best medical management
  intervention type: Device
  intervention name: Remote ischemic conditioning
  description: The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
  arm group label: Intervention group
  intervention type: Device
  intervention name: Sham remote ischemic conditioning
  description: The RIC procedure consists of five cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 60 mmHg during the ischemia period. RIC is performed within 24hours after stroke onset, and twice daily for the subsequent 7 days.
  arm group label: Sham group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chuanjie Wu, M.D.
  role: Study Director
  affiliation: Xuanwu Hospital of Capital Medical University
  last name: Xunming Ji, M.D. Ph.D
  phone: 861013120136877
  email: jixunming@vip.163.com; 1730812302@qq.com
  last name: Lina Jia, M.D.
  phone: +8615901588600
  email: 1730812302@qq.com
  citation: Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
  PMID: 25612858
  citation: Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
  PMID: 26343840
  citation: Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
  PMID: 27733675
  citation: Chamorro A, Meisel A, Planas AM, Urra X, van de Beek D, Veltkamp R. The immunology of acute stroke. Nat Rev Neurol. 2012 Jun 5;8(7):401-10. doi: 10.1038/nrneurol.2012.98.
  PMID: 22664787
  citation: Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med. 2011 Jul 7;17(7):796-808. doi: 10.1038/nm.2399.
  PMID: 21738161
  citation: Chamorro A, Urra X, Planas AM. Infection after acute ischemic stroke: a manifestation of brain-induced immunodepression. Stroke. 2007 Mar;38(3):1097-103. doi: 10.1161/01.STR.0000258346.68966.9d. Epub 2007 Jan 25.
  PMID: 17255542
  citation: Randhawa PK, Bali A, Jaggi AS. RIPC for multiorgan salvage in clinical settings: evolution of concept, evidences and mechanisms. Eur J Pharmacol. 2015 Jan 5;746:317-32. doi: 10.1016/j.ejphar.2014.08.016. Epub 2014 Aug 28.
  PMID: 25176179
  responsible party type: Principal Investigator
  investigator affiliation: Capital Medical University
  investigator full name: Ji Xunming,MD,PhD
  investigator title: Professor
  mesh term: Pneumonia
  mesh term: Stroke