<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/NCT02189928</url>
  </required_header>
  <id_info>
    <org_study_id>P14/01_RESCUE BRAIN</org_study_id>
    <secondary_id>2014-A00104-43</secondary_id>
    <nct_id>NCT02189928</nct_id>
  </id_info>
  <brief_title>REmote iSchemic Conditioning in acUtE BRAin INfarction Study</brief_title>
  <acronym>RESCUE-BRAIN</acronym>
  <official_title>Lower Limb Ischaemic Per-conditioning in Acute Cerebral Infarction (&lt;H6): Multicenter Randomized Study With Stratification on IV Thrombolysis and PROBE Design (Prospective Randomized Open Trial With Blinded End-Point)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unité de Recherche Clinique Paris IDF Ouest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Versailles Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first&#xD;
      cause of acquired disability, and the 2nd cause of dementia and death. The only approved&#xD;
      treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose&#xD;
      objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few&#xD;
      patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is&#xD;
      mainly correlated to the final infarct size. The objective of neuroprotective treatments is&#xD;
      to reduce the final size of the cerebral infarction.&#xD;
&#xD;
      The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral&#xD;
      ischemia by reducing the final size of cerebral infarction animal models. The per-CID&#xD;
      corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member&#xD;
      with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized&#xD;
      control trial involving 250 patients within 6 first hours of myocardial infarction and&#xD;
      candidate for primary angioplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (&lt;H6) and day 1 in the 2 groups of patients ( Remote Ischemic Perconditioning and control)</measure>
    <time_frame>24 hours</time_frame>
    <description>Central lecture of brain MRI, blinded to clinical data, randomisation group and day of MRI realization ( day 0 or day 1) Endpoint criteria: DWI volume d1-d0 (cc) measured by a dedicated software (Neurinfarct) Comparison of DWI volume d1-d0 between the 2 groups ( Per-CID group and control)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with Modified Rankin Scale (mRS) &lt;2 at 3 months in the 2 groups (PerCID and control)</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of patients with Modified Rankin Scale (mRS) &lt;2 ( i.e. favorable outcome with no disability) at 3 months in the 2 groups (PerCID and control)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>safety of remote perconditioning ischemic process</measure>
    <time_frame>7 days</time_frame>
    <description>- Rate of lower limb ischemia and deep venous thrombosis in Per CID group</description>
  </other_outcome>
  <other_outcome>
    <measure>safety of remote perconditioning ischemic process</measure>
    <time_frame>7 days</time_frame>
    <description>Rate of early neurological worsening (NIHSS score (d1- d0) &gt; 4 points) in Per-CID and control group</description>
  </other_outcome>
  <other_outcome>
    <measure>safety of remote perconditioning ischemic process</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>With per-CID protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without per-CID protocol</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care patients (thrombolysis or not).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lower limb tourniquet</intervention_name>
    <description>Lower limb tourniquet will be put on half thigh. The protocol will include 4 cycles of inflation cuff 110 mm Hg above systolic blood pressure followed by 4 cycles of deflation in between.&#xD;
The total duration of per-CID protocol will be 40 minutes (4 phases of 5 minutes inflations' of and 4 phases of 5 minutes deflations').</description>
    <arm_group_label>With per-CID protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Without per-CID protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years&#xD;
&#xD;
          -  Carotid ischemic stroke&#xD;
&#xD;
          -  NIHSS score between 5 and 25&#xD;
&#xD;
          -  Brain MRI performed within 6 hours from symptoms onset&#xD;
&#xD;
          -  Obtaining a written informed consent of the patient or a third party (parent or&#xD;
             close), or emergency inclusion process&#xD;
&#xD;
          -  Affiliated with a Medicare (or rightful beneficiary)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a leg ulcer or a bad skin condition in the lower limbs&#xD;
&#xD;
          -  History of arterial occlusive disease of the lower limbs&#xD;
&#xD;
          -  Sickle cell disease known (risk of vaso-occlusive crisis)&#xD;
&#xD;
          -  History of phlebitis in the lower limbs&#xD;
&#xD;
          -  History of cerebral infarction older than 3 months&#xD;
&#xD;
          -  Participation in another interventional acute phase protocol&#xD;
&#xD;
          -  Patients under guardianship&#xD;
&#xD;
          -  Pathologies involving life-threatening within 6 months and making it impossible to&#xD;
             evaluate to 3 months&#xD;
&#xD;
          -  Patient non-self before the ischemic stroke (Rankin Score previous&gt; 2)&#xD;
&#xD;
          -  Pregnant Women&#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>Fernando PICO, Neurology Department head</last_name>
    <role>Principal Investigator</role>
    <affiliation>Versailles Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil-Essonne</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pitie-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>78018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>September 3, 2018</last_update_submitted>
  <last_update_submitted_qc>September 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Versailles Hospital</investigator_affiliation>
    <investigator_full_name>Pr Fernando PICO</investigator_full_name>
    <investigator_title>Investigator coordinator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 31, 2021</submitted>
    <returned>February 18, 2021</returned>
  </pending_results>
  <!-- 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/NCT02189928
org study id: P14/01_RESCUE BRAIN
secondary id: 2014-A00104-43
nct id: NCT02189928
lead sponsor: 
collaborator: 
has dmc: Yes
Cerebral infarction is the most common form of stroke (80% of strokes). Stroke is the first
      cause of acquired disability, and the 2nd cause of dementia and death. The only approved
      treatment in the first 4.5 hour is intravenous rt-PA thrombolysis (Actilyse ®) whose
      objective is recanalization of occluded artery and reperfusion of the brain parenchyma. Few
      patients are treated (1-5%) and they keep disability in 50-60% of cases. This handicap is
      mainly correlated to the final infarct size. The objective of neuroprotective treatments is
      to reduce the final size of the cerebral infarction.

      The per-conditioning remote ischemic (Per-CID) showed a neuroprotective effect in cerebral
      ischemia by reducing the final size of cerebral infarction animal models. The per-CID
      corresponds, in cases of cerebral ischemia, to iterative ischemia realization of a member
      with a cuff. In humans, the per-CID has shown a cardioprotective effect in a randomized
      control trial involving 250 patients within 6 first hours of myocardial infarction and
      candidate for primary angioplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Brain MRI changes of DWI ( Diffusion-Weighted Imaging) brain infarction volume (cc) between baseline (<H6) and day 1 in the 2 groups of patients ( Remote Ischemic Perconditioning and control)
time frame: 24 hours
description: Central lecture of brain MRI, blinded to clinical data, randomisation group and day of MRI realization ( day 0 or day 1) Endpoint criteria: DWI volume d1-d0 (cc) measured by a dedicated software (Neurinfarct) Comparison of DWI volume d1-d0 between the 2 groups ( Per-CID group and control)
measure: Percentage of patients with Modified Rankin Scale (mRS) <2 at 3 months in the 2 groups (PerCID and control)
time frame: 3 months
description: Percentage of patients with Modified Rankin Scale (mRS) <2 ( i.e. favorable outcome with no disability) at 3 months in the 2 groups (PerCID and control)
measure: safety of remote perconditioning ischemic process
time frame: 7 days
description: - Rate of lower limb ischemia and deep venous thrombosis in Per CID group
measure: safety of remote perconditioning ischemic process
time frame: 7 days
description: Rate of early neurological worsening (NIHSS score (d1- d0) > 4 points) in Per-CID and control group
measure: safety of remote perconditioning ischemic process
time frame: 7 days
description: Percentage of hemorrhagic transformation in case of IV thrombolysis in the 2 groups
arm group label: With per-CID protocol
arm group type: Experimental
description: Usual care patients (thrombolysis or not ) with remote ischemic per-conditioning using an electronic tourniquet .
arm group label: Without per-CID protocol
arm group type: Other
description: Usual care patients (thrombolysis or not).
intervention type: Device
intervention name: Lower limb tourniquet
description: Lower limb tourniquet will be put on half thigh. The protocol will include 4 cycles of inflation cuff 110 mm Hg above systolic blood pressure followed by 4 cycles of deflation in between.
The total duration of per-CID protocol will be 40 minutes (4 phases of 5 minutes inflations' of and 4 phases of 5 minutes deflations').
arm group label: With per-CID protocol
intervention type: Other
intervention name: Usual care
arm group label: Without per-CID protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando PICO, Neurology Department head
role: Principal Investigator
affiliation: Versailles Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Versailles Hospital
investigator full name: Pr Fernando PICO
investigator title: Investigator coordinator
mesh term: Cerebral Infarction
mesh term: Infarction
sharing ipd: Undecided
submitted: January 31, 2021
returned: February 18, 2021