<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/NCT04439643</url>
  </required_header>
  <id_info>
    <org_study_id>PoSTCARD</org_study_id>
    <nct_id>NCT04439643</nct_id>
  </id_info>
  <brief_title>Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)</brief_title>
  <acronym>PoSTCARD</acronym>
  <official_title>Plaque Stratification Using Ccta in Coronary ARtery Disease (PoSTCARD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elucid Bioimaging Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of South Carolina</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Develop time-to-event prediction and plaque phenotype classification models for patients with&#xD;
      known or suspected coronary artery disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Develop time-to-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 last known well dates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Actual">July 30, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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>Time to adverse outcome</measure>
    <time_frame>&gt;= 2 years</time_frame>
    <description>Develop time-to-event model for major adverse cardiac events (MACE) 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="Actual">800</enrollment>
  <condition>Coronary Artery Disease</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>Device</intervention_type>
    <intervention_name>vascuCAP</intervention_name>
    <description>time to 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>
        Reverse chronological, all-comers, design, adjusted for demographic factors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have successfully completed at least one (possibly multiple) CCTA for&#xD;
             known or suspected coronary artery disease, which was positive for coronary&#xD;
             atherosclerotic changes.&#xD;
&#xD;
          -  Subject must have been ≥ 18 years of age at the time of the CCTA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a history of percutaneous coronary intervention (PCI) with stent&#xD;
             implantation and/or coronary artery bypass grafting (CABG)&#xD;
&#xD;
          -  CCTA taken less than 3 months after deployment of new scanner&#xD;
&#xD;
          -  Subject with insufficient CCTA image quality&#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>Andrew J. Buckler, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elucid Bioimaging Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT04439643
org study id: PoSTCARD
nct id: NCT04439643
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Develop time-to-event prediction and plaque phenotype classification models for patients with
      known or suspected coronary artery disease.
Develop time-to-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 last known well dates.
observational model: Cohort
time perspective: Retrospective
measure: Time to adverse outcome
time frame: >= 2 years
description: Develop time-to-event model for major adverse cardiac events (MACE) 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: Device
intervention name: vascuCAP
description: time to event and phenotype classification model
arm group label: Development / training
arm group label: Sequestered / test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew J. Buckler, MS
role: Principal Investigator
affiliation: Elucid Bioimaging Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No