<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/NCT02184936</url>
  </required_header>
  <id_info>
    <org_study_id>24416</org_study_id>
    <nct_id>NCT02184936</nct_id>
  </id_info>
  <brief_title>Measuring Collaterals With Multi-phase CT Angiography in Patients With Ischemic Stroke</brief_title>
  <acronym>PRove-IT</acronym>
  <official_title>Precise and Rapid Assessment of Collaterals Using Multi-phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carol Kenney</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment of acute ischemic stroke (AIS) is aimed at salvaging viable but ischemic brain by&#xD;
      opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time&#xD;
      saved while making critical decisions correctly is vital in AIS management. Conventional&#xD;
      angiography is invasive, resource intensive and not feasible as a fast diagnostic tool.&#xD;
      Perfusion CT and MRI are both susceptible to patient motion, need trained personnel to&#xD;
      process and take at least 10-30 min to acquire and interpret. The investigators have&#xD;
      developed a new imaging tool, multi-phase CT Angiography (CTA), which generates multiple time&#xD;
      resolved images of backfilling arteries beyond a blocked artery filled by collaterals.&#xD;
&#xD;
      Investigators seek to determine: i) if patients with AIS will have a differential clinical&#xD;
      response to early recanalization based on collateral status assessed on multi-phase CTA, ii)&#xD;
      if the extent to which collateral assessment on multi-phase CTA resembles perfusion CT in&#xD;
      predicting which patients will have good clinical outcome with early recanalization, iii)&#xD;
      Identify determinants of variability in native collateral status in patients with acute&#xD;
      ischemic stroke.&#xD;
&#xD;
      Investigators hypothesize that patients with good and intermediate collaterals on multi-phase&#xD;
      CTA achieve good clinical outcome with early recanalization (within 4 hours of baseline&#xD;
      imaging); patients with poor collaterals do not do well even with early recanalization.&#xD;
&#xD;
      Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive&#xD;
      patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with&#xD;
      evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other&#xD;
      comprehensive stroke centers will recruit patients into this study. Primary outcome is&#xD;
      defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or&#xD;
      an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day&#xD;
      modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic&#xD;
      improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct&#xD;
      volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II&#xD;
      criteria) at 24 hrs.&#xD;
&#xD;
      Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and&#xD;
      thrombolysis decisions in the setting of AIS which is widely available, and can quickly and&#xD;
      reliably detect salvageable brain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major neurological improvement at 24 hours</measure>
    <time_frame>24 hours post stroke onset</time_frame>
    <description>defined as a NIHSS score of 0 to 2 at 24 hours or an 8-point drop in NIHSS score from baseline to 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90 day clinical outcome</measure>
    <time_frame>90 days</time_frame>
    <description>90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS&#xD;
Ordinal (shift) analysis across the mRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent neurologic improvement comparing NIHSS at baseline to 24 hours</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day NIHSS score 0-2</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcome</measure>
    <time_frame>24 hours</time_frame>
    <description>infarct volume on 24 hour imaging and parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II criteria) at 24 hrs</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>acute ischemic stroke</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard of care</intervention_name>
    <arm_group_label>acute ischemic stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with&#xD;
        evidence of intracranial occlusion on routine CTA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient presenting to the emergency department with symptoms consistent with ischemic&#xD;
             stroke.&#xD;
&#xD;
          2. Age &gt; 18 yrs.&#xD;
&#xD;
          3. Baseline imaging including multi-phase CTA done within 12 hours of stroke symptom&#xD;
             onset and initiated before recanalization therapy.&#xD;
&#xD;
          4. Evidence of a visible and symptomatic intracranial occlusion on baseline&#xD;
             CT-angiography (intracranial ICA, M1 MCA segment +/- intracranial ICA, proximal M2&#xD;
             MCA).&#xD;
&#xD;
          5. Treatment with IV tPA and/or IA therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intracranial hemorrhage (ICH) identified on baseline CT.&#xD;
&#xD;
          2. Previous moderate to large stroke in the ipsilesional hemisphere.&#xD;
&#xD;
          3. Modified Rankin Scale &gt; 2 at baseline.&#xD;
&#xD;
          4. Unable to have CT-angio performed due to recent estimated creatinine clearance eCCr&lt;60&#xD;
             ml/min, contrast allergy or other reasons.&#xD;
&#xD;
          5. Participation in another study that results in the patient receiving an&#xD;
             investigational drug or therapy.&#xD;
&#xD;
          6. Any terminal illness (patient not expected to survive &gt; 1 year).&#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>Bijoy Menon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary, Calgary Stroke Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale Sant'Anna · Department of Neurology</name>
      <address>
        <city>Ferrara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.aspectsinstroke.com</url>
    <description>collateral section</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>October 26, 2017</last_update_submitted>
  <last_update_submitted_qc>October 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Carol Kenney</investigator_full_name>
    <investigator_title>Study co-ordinator</investigator_title>
  </responsible_party>
  <keyword>CT Angiography, CT Perfusion, Ischemic Stroke, Collaterals</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant date will be shared, overall data( anonymous) will be available and shared</ipd_description>
  </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/NCT02184936
org study id: 24416
nct id: NCT02184936
lead sponsor: 
has dmc: No
Treatment of acute ischemic stroke (AIS) is aimed at salvaging viable but ischemic brain by
      opening the occluded artery and restoring anterograde perfusion as quickly as possible. Time
      saved while making critical decisions correctly is vital in AIS management. Conventional
      angiography is invasive, resource intensive and not feasible as a fast diagnostic tool.
      Perfusion CT and MRI are both susceptible to patient motion, need trained personnel to
      process and take at least 10-30 min to acquire and interpret. The investigators have
      developed a new imaging tool, multi-phase CT Angiography (CTA), which generates multiple time
      resolved images of backfilling arteries beyond a blocked artery filled by collaterals.

      Investigators seek to determine: i) if patients with AIS will have a differential clinical
      response to early recanalization based on collateral status assessed on multi-phase CTA, ii)
      if the extent to which collateral assessment on multi-phase CTA resembles perfusion CT in
      predicting which patients will have good clinical outcome with early recanalization, iii)
      Identify determinants of variability in native collateral status in patients with acute
      ischemic stroke.

      Investigators hypothesize that patients with good and intermediate collaterals on multi-phase
      CTA achieve good clinical outcome with early recanalization (within 4 hours of baseline
      imaging); patients with poor collaterals do not do well even with early recanalization.

      Prove-IT is a prospective multi-center hospital-based cohort study of 500 consecutive
      patients with acute ischemic stroke presenting within 12 hours of stroke symptom onset with
      evidence of intracranial occlusion on routine CTA over 3 years. Calgary and seven other
      comprehensive stroke centers will recruit patients into this study. Primary outcome is
      defined as a National Institute of Health Stroke Scale (NIHSS) score of 0 to 2 at 24 hours or
      an 8-point drop in NIHSS score from baseline to 24 hours. Secondary outcomes are a) 90-day
      modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS; b) percent neurologic
      improvement comparing NIHSS at baseline to 24 hours; c) 90-day NIHSS score 0-2; d) infarct
      volume on 24 hour imaging and e) parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II
      criteria) at 24 hrs.

      Prove-IT looks to establish the ideal imaging selection tool for intra-arterial (IA) and
      thrombolysis decisions in the setting of AIS which is widely available, and can quickly and
      reliably detect salvageable brain.
observational model: Cohort
time perspective: Prospective
measure: Major neurological improvement at 24 hours
time frame: 24 hours post stroke onset
description: defined as a NIHSS score of 0 to 2 at 24 hours or an 8-point drop in NIHSS score from baseline to 24 hours.
measure: 90 day clinical outcome
time frame: 90 days
description: 90-day modified Rankin Score (mRS) 0-2 or equal to the pre-stroke mRS
Ordinal (shift) analysis across the mRS scale
measure: percent neurologic improvement comparing NIHSS at baseline to 24 hours
time frame: 24 hours
measure: 90-day NIHSS score 0-2
time frame: 90 days
measure: Radiological outcome
time frame: 24 hours
description: infarct volume on 24 hour imaging and parenchymal intracerebral hemorrhage type 1 and 2 (ECASS II criteria) at 24 hrs
arm group label: acute ischemic stroke
intervention type: Other
intervention name: standard of care
arm group label: acute ischemic stroke
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bijoy Menon, MD
role: Principal Investigator
affiliation: University of Calgary, Calgary Stroke Program
facility: 
facility: 
country: Canada
country: Italy
url: http://www.aspectsinstroke.com
description: collateral section
responsible party type: Sponsor-Investigator
investigator affiliation: University of Calgary
investigator full name: Carol Kenney
investigator title: Study co-ordinator
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No
ipd description: No individual participant date will be shared, overall data( anonymous) will be available and shared