<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/NCT03265860</url>
  </required_header>
  <id_info>
    <org_study_id>ALR_2017_5</org_study_id>
    <nct_id>NCT03265860</nct_id>
  </id_info>
  <brief_title>Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging</brief_title>
  <acronym>IMPROVES</acronym>
  <official_title>Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Ischemic strokes are the first cause of handicap in adult people, the second cause of&#xD;
      dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial&#xD;
      assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to&#xD;
      determine the best treatment.&#xD;
&#xD;
      The conventional diffusion weighted imaging sequence is used to establish the diagnosis and&#xD;
      to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also&#xD;
      used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra&#xD;
      corresponding to territories that could be saved with appropriate treatments.&#xD;
&#xD;
      IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract&#xD;
      four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and&#xD;
      correlated to the microvascular perfusion.&#xD;
&#xD;
      It's a quick sequence with no need of contrast injection and allowing a perfect&#xD;
      coregistration with the true diffusion. It has been validated in many pathologies but not in&#xD;
      acute strokes.&#xD;
&#xD;
      The feasibility of this sequence in acute ischemic strokes has already been assessed with&#xD;
      interesting results.&#xD;
&#xD;
      The study aims to assess the correlation between the quantitative values of IVIM at initial&#xD;
      MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">June 14, 2021</completion_date>
  <primary_completion_date type="Actual">March 14, 2021</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>Correlation between quantitative values of IntraVoxel Incoherent Motion at initial Magnetic Resonance Imaging (MRI) and the modified Rankin Scale (mRS) at 3 months after an acute ischemic stroke.</measure>
    <time_frame>3 months</time_frame>
    <description>IntraVoxel Incoherent Motion is a diffusion sequence which allows to extract four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and correlated to the microvascular perfusion.&#xD;
We aim to assess the correlation between the quantitative values of IVIM at initial exam and the mRS score 3 months after an acute ischemic stroke.</description>
  </primary_outcome>
  <enrollment type="Actual">274</enrollment>
  <condition>Stroke</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IntraVoxel Incoherent Motion sequence</intervention_name>
    <description>The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an acute ischemic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  Admitted for an acute ischemic stroke&#xD;
&#xD;
          -  Affiliated to a Social Security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindications to MRI&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#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>Augustin Lecler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ophtalmologique A. de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</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>
    <mesh_term>Ischemic Stroke</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/NCT03265860
org study id: ALR_2017_5
nct id: NCT03265860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ischemic strokes are the first cause of handicap in adult people, the second cause of
      dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial
      assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to
      determine the best treatment.

      The conventional diffusion weighted imaging sequence is used to establish the diagnosis and
      to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also
      used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra
      corresponding to territories that could be saved with appropriate treatments.

      IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract
      four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and
      correlated to the microvascular perfusion.

      It's a quick sequence with no need of contrast injection and allowing a perfect
      coregistration with the true diffusion. It has been validated in many pathologies but not in
      acute strokes.

      The feasibility of this sequence in acute ischemic strokes has already been assessed with
      interesting results.

      The study aims to assess the correlation between the quantitative values of IVIM at initial
      MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.
observational model: Case-Only
time perspective: Prospective
measure: Correlation between quantitative values of IntraVoxel Incoherent Motion at initial Magnetic Resonance Imaging (MRI) and the modified Rankin Scale (mRS) at 3 months after an acute ischemic stroke.
time frame: 3 months
description: IntraVoxel Incoherent Motion is a diffusion sequence which allows to extract four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and correlated to the microvascular perfusion.
We aim to assess the correlation between the quantitative values of IVIM at initial exam and the mRS score 3 months after an acute ischemic stroke.
intervention type: Device
intervention name: IntraVoxel Incoherent Motion sequence
description: The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Augustin Lecler, MD
role: Principal Investigator
affiliation: Fondation Ophtalmologique A. de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: Undecided