<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/NCT02988492</url>
  </required_header>
  <id_info>
    <org_study_id>MR-RETRIEVE Protocol</org_study_id>
    <nct_id>NCT02988492</nct_id>
  </id_info>
  <brief_title>Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization</brief_title>
  <official_title>Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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 newest generation of stent---retrievers results in higher recanalization rates and faster&#xD;
      recanalization time compared to older generation endovascular therapies for acute stroke.&#xD;
      Advanced neuroimaging can potentially improve the assessment of infarct core and inform&#xD;
      decision---making in patients being considered for endovascular therapy. Evaluation of&#xD;
      infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of&#xD;
      CTP in predicting core infarct in acute stroke has been limited because recanalization status&#xD;
      was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI.&#xD;
      These two limitations can now be addressed: the new generation of stent---retrievers allows&#xD;
      accurate determination recanalization time; evaluating the test characteristics of CTP using&#xD;
      24 hour DWI---MRI as the reference standard can be readily performed.&#xD;
&#xD;
      We aim to prospectively investigate the sensitivity and specificity of whole---brain CTP in&#xD;
      predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation&#xD;
      occlusions successfully recanalized with endovascular treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the sensitivity and specificity of CTP</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The primary outcome of our study is to evaluate the sensitivity and specificity of CTP in predicting infarct on 24 hour DWI---MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlate advanced imaging to clinical outcome</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The secondary outcome of our study is to correlate advanced imaging to clinical outcome at 30 days.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>MRI perfusion imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>MRI screening will be performed as per standard-of-care by the MRI technologist staff. Imaging will be performed with 1.5 T or 3 T systems (Magnetom Vision; Siemens, Erlangen, Germany) using a multisection, single shot, spin echo, echo planer imaging sequence. Diffusion gradients will be applied in each of the x, y and z directions with three b values (0, 500 and 1000 s/mm2). Imaging parameters include a TE of 94 ms, field of view of 23 cm, matrix of 128 and section thickness of 5.5 mm for the 1.5 T system and a TE of 83 ms, field of view of 23 cm, matrix of 128 and section thickness of 3 mm for the 3 T system. Conventional spin echo imaging also will be performed at each examination under T1 and T2 weighted conditions, with a fluid attenuated inversion recovery sequence and Time-of-flight MRA of the Circle-of-Willis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI perfusion imaging</intervention_name>
    <description>Evaluate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.</description>
    <arm_group_label>MRI perfusion imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Admission NECT, CTA neck and COW or multi-phase CTA or CTP. Follow---up 24 hr&#xD;
             DWI---MRI performed&#xD;
&#xD;
          2. Endovascular therapy performed for acute anterior circulation stroke as per clinical&#xD;
             practice.&#xD;
&#xD;
          3. Patient with an angiographically documented ICA, M1 or M2 occlusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#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>Daniela Iancu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 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>
  </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/NCT02988492
org study id: MR-RETRIEVE Protocol
nct id: NCT02988492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The newest generation of stent---retrievers results in higher recanalization rates and faster
      recanalization time compared to older generation endovascular therapies for acute stroke.
      Advanced neuroimaging can potentially improve the assessment of infarct core and inform
      decision---making in patients being considered for endovascular therapy. Evaluation of
      infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of
      CTP in predicting core infarct in acute stroke has been limited because recanalization status
      was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI.
      These two limitations can now be addressed: the new generation of stent---retrievers allows
      accurate determination recanalization time; evaluating the test characteristics of CTP using
      24 hour DWI---MRI as the reference standard can be readily performed.

      We aim to prospectively investigate the sensitivity and specificity of whole---brain CTP in
      predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation
      occlusions successfully recanalized with endovascular treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate the sensitivity and specificity of CTP
time frame: Up to 24 months
description: The primary outcome of our study is to evaluate the sensitivity and specificity of CTP in predicting infarct on 24 hour DWI---MRI.
measure: Correlate advanced imaging to clinical outcome
time frame: Up to 24 months
description: The secondary outcome of our study is to correlate advanced imaging to clinical outcome at 30 days.
arm group label: MRI perfusion imaging
arm group type: Other
description: MRI screening will be performed as per standard-of-care by the MRI technologist staff. Imaging will be performed with 1.5 T or 3 T systems (Magnetom Vision; Siemens, Erlangen, Germany) using a multisection, single shot, spin echo, echo planer imaging sequence. Diffusion gradients will be applied in each of the x, y and z directions with three b values (0, 500 and 1000 s/mm2). Imaging parameters include a TE of 94 ms, field of view of 23 cm, matrix of 128 and section thickness of 5.5 mm for the 1.5 T system and a TE of 83 ms, field of view of 23 cm, matrix of 128 and section thickness of 3 mm for the 3 T system. Conventional spin echo imaging also will be performed at each examination under T1 and T2 weighted conditions, with a fluid attenuated inversion recovery sequence and Time-of-flight MRA of the Circle-of-Willis.
intervention type: Device
intervention name: MRI perfusion imaging
description: Evaluate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.
arm group label: MRI perfusion imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniela Iancu, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided