<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/NCT03245957</url>
  </required_header>
  <id_info>
    <org_study_id>2016/CHU/06</org_study_id>
    <nct_id>NCT03245957</nct_id>
  </id_info>
  <brief_title>HDL Dysfunction During the Acute Stage of Stroke</brief_title>
  <acronym>RUSH</acronym>
  <official_title>HDL Dysfunction During the Acute Stage of Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</source>
  <oversight_info>
    <has_dmc>No</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 study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL&#xD;
      dysfunction during the acute stage of ischemic and haemorrhagic strokes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.&#xD;
&#xD;
      Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3&#xD;
      cases.&#xD;
&#xD;
      The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could&#xD;
      be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent&#xD;
      marker of early stage of ischemic stroke.&#xD;
&#xD;
      Plasma MPO levels could also be discriminant regarding the mimick strokes in patient&#xD;
      exhibiting stroke clinical picture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma MPO concentrations</measure>
    <time_frame>Through study completion, an average of 6 hours</time_frame>
    <description>Assessment of plasma MPO concentrations during acute stage of stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HDL-MPO concentrations</measure>
    <time_frame>Through study completion, an average of 6 hours</time_frame>
    <description>Assessment of HDL-MPO concentrations during acute stage of stroke</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HDL dysfunction</measure>
    <time_frame>Through study completion, an average of 6 hours</time_frame>
    <description>Assessment of HDL function using inhibition test on cell culture</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>Ischemic stroke</arm_group_label>
    <description>Patients with ischemic stroke diagnosed by MRI or CT scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haemorrhagic stroke</arm_group_label>
    <description>Patients without haemorrhagic stroke diagnosed by MRI or CT scan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mimick stroke</arm_group_label>
    <description>Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ischemic stroke</intervention_name>
    <description>Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan</description>
    <arm_group_label>Ischemic stroke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Haemorrhagic stroke</intervention_name>
    <description>Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan</description>
    <arm_group_label>Haemorrhagic stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with clinical picture of early stage of stroke with the first signed lasting&#xD;
        for less than 12 hours&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with less than 12 hours stroke clinical signs:&#xD;
&#xD;
          -  hemiparesis or hemiplegia&#xD;
&#xD;
          -  unilateral sensitivity disorder&#xD;
&#xD;
          -  language impairment&#xD;
&#xD;
          -  balance disorder&#xD;
&#xD;
          -  dizziness, bilateral or monocular vision totally or partially lost&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  head trauma since the last 3 months&#xD;
&#xD;
          -  stroke since the last 3 months&#xD;
&#xD;
          -  myocardial infarction since the last 3 months&#xD;
&#xD;
          -  patient disagrees to be enrolled in the study&#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>David COURET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hpospitalier Universitaire de La REUNION</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine JUHEL, PHD</last_name>
    <phone>+262262359949</phone>
    <email>christine.juhel@chu-reunion.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David COURET, MD</last_name>
    <phone>+262262359000</phone>
    <email>david.couret@chu-reunion.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Reunion Island</name>
      <address>
        <city>Saint-Pierre</city>
        <state>Reunion Island</state>
        <zip>97410</zip>
        <country>Réunion</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>COURET DAVID, MD</last_name>
      <phone>+262262359000</phone>
      <email>david.couret@chu-reunion.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>Réunion</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03245957
org study id: 2016/CHU/06
nct id: NCT03245957
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL
      dysfunction during the acute stage of ischemic and haemorrhagic strokes.
MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.

      Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3
      cases.

      The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could
      be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent
      marker of early stage of ischemic stroke.

      Plasma MPO levels could also be discriminant regarding the mimick strokes in patient
      exhibiting stroke clinical picture.
observational model: Case-Only
time perspective: Prospective
measure: Plasma MPO concentrations
time frame: Through study completion, an average of 6 hours
description: Assessment of plasma MPO concentrations during acute stage of stroke
measure: HDL-MPO concentrations
time frame: Through study completion, an average of 6 hours
description: Assessment of HDL-MPO concentrations during acute stage of stroke
measure: HDL dysfunction
time frame: Through study completion, an average of 6 hours
description: Assessment of HDL function using inhibition test on cell culture
arm group label: Ischemic stroke
description: Patients with ischemic stroke diagnosed by MRI or CT scan
arm group label: Haemorrhagic stroke
description: Patients without haemorrhagic stroke diagnosed by MRI or CT scan
arm group label: Mimick stroke
description: Patients without haemorrhagic or ischemic stroke diagnosed by MRI or CT scan
intervention type: Other
intervention name: Ischemic stroke
description: Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
arm group label: Ischemic stroke
intervention type: Other
intervention name: Haemorrhagic stroke
description: Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
arm group label: Haemorrhagic stroke
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David COURET, MD
role: Principal Investigator
affiliation: Centre Hpospitalier Universitaire de La REUNION
last name: Christine JUHEL, PHD
phone: +262262359949
email: christine.juhel@chu-reunion.fr
last name: David COURET, MD
phone: +262262359000
email: david.couret@chu-reunion.fr
facility: 
status: Recruiting
contact: 
country: Réunion
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No