<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/NCT04448353</url>
  </required_header>
  <id_info>
    <org_study_id>CRISP</org_study_id>
    <nct_id>NCT04448353</nct_id>
  </id_info>
  <brief_title>Carotid Risk Prediction (CRISP) Consortium</brief_title>
  <acronym>CRISP</acronym>
  <official_title>Carotid Risk Prediction (CRISP) Consortium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elucid Bioimaging Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland, College Park</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Elucid Bioimaging Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Develop adverse event prediction and plaque phenotype classification models for patients with&#xD;
      known or suspected carotid artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Develop adverse event prediction and plaque phenotype classification models using plaque&#xD;
      morphology and composition assessment of CTA which has been validated by histology, applied&#xD;
      to representative cohort of patients. Generalizability of models is enhanced by using&#xD;
      validated rather than only raw image inputs. Demographic, clinical, and outcome data is&#xD;
      collected for enrolled patients as well as information on events and interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse outcome model performance</measure>
    <time_frame>2 years</time_frame>
    <description>Develop adverse event model for major adverse neurological events (MANE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Carotid Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>Development / training</arm_group_label>
    <description>Selected by stratified partitioning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequestered / test</arm_group_label>
    <description>Selected by stratified partitioning</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>vascuCAP</intervention_name>
    <description>adverse event and phenotype classification model</description>
    <arm_group_label>Development / training</arm_group_label>
    <arm_group_label>Sequestered / test</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All-comers, design, adjusted for demographic factors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient&#xD;
             quality as documented in the vascuCAP Reading Manual.&#xD;
&#xD;
          -  Atherosclerotic plaque must be visualized within the carotid artery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects without visible plaque within the carotid artery&#xD;
&#xD;
          -  Subject with insufficient CTA image quality (defined strictly as documented in the&#xD;
             vascuCAP Reading Manual)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brajesh K. Lal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, College Park</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew J Buckler, MS</last_name>
    <phone>9784731986</phone>
    <email>andrew.buckler@elucidbio.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brajesh K Lal, MD</last_name>
      <phone>410-328-5840</phone>
      <email>blal@som.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Maryland, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brajesh K Lal, MD</last_name>
      <phone>410-328-5840</phone>
      <email>blal@som.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin DeMarco, MD</last_name>
      <phone>301-295-4428</phone>
      <email>james.k.demarco.civ@mail.mil</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ajay Gupta, MD</last_name>
      <phone>212-746-6000</phone>
      <email>ajg9004@med.cornell.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Harrington (Affiliated with Case Western Reserve University)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vikram Kashyap, MD</last_name>
      <phone>216-250-9840</phone>
      <email>vikram.kashyap@uhhospitals.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 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>Carotid Artery Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 29, 2022</submitted>
    <returned>August 9, 2022</returned>
    <submitted>August 9, 2022</submitted>
    <returned>July 6, 2023</returned>
    <submitted>September 8, 2023</submitted>
  </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/NCT04448353
org study id: CRISP
nct id: NCT04448353
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Develop adverse event prediction and plaque phenotype classification models for patients with
      known or suspected carotid artery disease.
Develop adverse event prediction and plaque phenotype classification models using plaque
      morphology and composition assessment of CTA which has been validated by histology, applied
      to representative cohort of patients. Generalizability of models is enhanced by using
      validated rather than only raw image inputs. Demographic, clinical, and outcome data is
      collected for enrolled patients as well as information on events and interventions.
observational model: Cohort
time perspective: Retrospective
measure: Adverse outcome model performance
time frame: 2 years
description: Develop adverse event model for major adverse neurological events (MANE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
arm group label: Development / training
description: Selected by stratified partitioning
arm group label: Sequestered / test
description: Selected by stratified partitioning
intervention type: Diagnostic Test
intervention name: vascuCAP
description: adverse event and phenotype classification model
arm group label: Development / training
arm group label: Sequestered / test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brajesh K. Lal, MD
role: Principal Investigator
affiliation: University of Maryland, College Park
last name: Andrew J Buckler, MS
phone: 9784731986
email: andrew.buckler@elucidbio.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Carotid Artery Diseases
mesh term: Atherosclerosis
sharing ipd: No
submitted: March 29, 2022
returned: August 9, 2022
submitted: August 9, 2022
returned: July 6, 2023
submitted: September 8, 2023