<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/NCT02223286</url>
  </required_header>
  <id_info>
    <org_study_id>CDX_000016</org_study_id>
    <secondary_id>UCU-CARD</secondary_id>
    <nct_id>NCT02223286</nct_id>
  </id_info>
  <brief_title>Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making</brief_title>
  <acronym>UCU-CARD</acronym>
  <official_title>Understanding Clinician Utilization of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Clinical Decision Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CardioDx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CardioDx</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene&#xD;
      Expression score (ASGES) in the clinical decision making process of patients who underwent&#xD;
      the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better&#xD;
      understand whether the use of the assay in clinical decision making resulted in changes in&#xD;
      noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or&#xD;
      invasive angiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective,&#xD;
      matched-cohort evaluation of diagnostic testing in a community-based cardiology practice&#xD;
      setting that used a personalized age, sex, and gene expression test during early work-up of&#xD;
      patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov,&#xD;
      NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after&#xD;
      initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced&#xD;
      diagnostic testing for patients who received the age, sex, and gene expression test (ASGES)&#xD;
      were compared with testing rates for matched historical controls (usual care). The study&#xD;
      hypothesis was that incorporating the age, sex, and gene expression testing early in the&#xD;
      diagnostic work-up pathway would permit the identification of patients for whom advanced&#xD;
      diagnostic testing was not required, thereby avoiding unnecessary testing and enabling&#xD;
      cardiologists to focus their diagnostic resources more efficiently.&#xD;
&#xD;
      This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a&#xD;
      community-based group cardiology practice that receives patients on referral from primary&#xD;
      care physicians and other specialists in the surrounding area. The practice incorporated age,&#xD;
      sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data&#xD;
      collection was completed in December 2013. Institutional Review Board (IRB) approval of the&#xD;
      study protocol was granted by Quorum Review. Informed consent waivers were granted as data&#xD;
      collection was retrospective and all data were de-identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary measure of this study is the number of advanced diagnostic tests in ASGES (treatment group) patients compared to the number of advanced diagnostic tests in non-ASGES (control group) patients.</measure>
    <time_frame>up to 24 months</time_frame>
    <description>The primary study endpoint was the percentage of patients for whom advanced diagnostic testing was ordered-stress testing with imaging, computed tomography angiography, or invasive coronary angiography.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">552</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Angina Pectoris</condition>
  <condition>Chest Pain</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Coronary Heart Disease</condition>
  <condition>CAD</condition>
  <condition>CVD</condition>
  <condition>CHD</condition>
  <arm_group>
    <arm_group_label>ASGES (Treatment Group)</arm_group_label>
    <description>Patients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ASGES (Control Group)</arm_group_label>
    <description>Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Corus CAD</intervention_name>
    <description>Age/Sex/Gene Expression Score</description>
    <arm_group_label>ASGES (Treatment Group)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patient population of interest and the main inclusion criterion for inclusion is the&#xD;
        occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD&#xD;
        or a history of prior myocardial infarction, and the utilization of Corus CAD (Age/Sex/Gene&#xD;
        Expression score - ASGES).&#xD;
&#xD;
        Additionally, subjects with similar chest pain (or angina equivalent) whom did not undergo&#xD;
        Corus CAD (ASGES) will be included as a control group, to understand the diagnostic&#xD;
        evaluation and management of patients prior to Corus CAD (ASGES) use.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptoms suggestive of CAD, according to the opinion of the site clinician&#xD;
&#xD;
          2. Age &gt;= 21 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of myocardial infarction (MI)&#xD;
&#xD;
          2. History of high risk unstable angina, systemic infections or systemic inflammatory&#xD;
             conditions&#xD;
&#xD;
          3. Current MI or acute coronary syndrome&#xD;
&#xD;
          4. Current New York Heart Association (NYHA) class III or IV congestive heart failure&#xD;
             symptoms&#xD;
&#xD;
          5. Known/documented CAD&#xD;
&#xD;
          6. History/current Diabetes Mellitus&#xD;
&#xD;
          7. Taking steroids, immunosuppressive agents, or chemotherapeutic agents, at time of&#xD;
             chest pain presentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Hoffman, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northeast Ohio Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lawrence Kline, DP</last_name>
    <role>Principal Investigator</role>
    <affiliation>John C. Lincoln Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaime Burkle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piedmont Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John C. Lincoln Heart Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Blue Ridge</city>
        <state>Georgia</state>
        <zip>30513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Associates</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Corus CAD</keyword>
  <keyword>ASGES</keyword>
  <keyword>Age/Sex/Gene Expression Score</keyword>
  <keyword>Gene Expression</keyword>
  <keyword>GES</keyword>
  <keyword>CAD</keyword>
  <keyword>CVD</keyword>
  <keyword>CHD</keyword>
  <keyword>Precision Medicine</keyword>
  <keyword>Clinical Utility</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Angina Pectoris</keyword>
  <keyword>Chest Pain</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>UCU-CARD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02223286
org study id: CDX_000016
secondary id: UCU-CARD
nct id: NCT02223286
lead sponsor: 
has dmc: No
The purpose of this study is to understand the use of Corus CAD also known as Age/Sex/Gene
      Expression score (ASGES) in the clinical decision making process of patients who underwent
      the evaluation of chest pain or anginal equivalent symptoms. Specifically, to better
      understand whether the use of the assay in clinical decision making resulted in changes in
      noninvasive diagnostic test ordering or diagnostic yield of additional tests ordered and/or
      invasive angiography.
The UCU-CARD (Understanding Clinician Utility-Cardiology) study is a retrospective,
      matched-cohort evaluation of diagnostic testing in a community-based cardiology practice
      setting that used a personalized age, sex, and gene expression test during early work-up of
      patients with symptoms suggestive of obstructive CAD (http://www.clinicaltrials.gov,
      NCT02223286). The study measured the rates of advanced cardiac diagnostic testing after
      initial work-up, including stress testing with imaging, CTA, or ICA. Rates of advanced
      diagnostic testing for patients who received the age, sex, and gene expression test (ASGES)
      were compared with testing rates for matched historical controls (usual care). The study
      hypothesis was that incorporating the age, sex, and gene expression testing early in the
      diagnostic work-up pathway would permit the identification of patients for whom advanced
      diagnostic testing was not required, thereby avoiding unnecessary testing and enabling
      cardiologists to focus their diagnostic resources more efficiently.

      This single-center study was conducted at the North Phoenix Heart Center (Phoenix, AZ), a
      community-based group cardiology practice that receives patients on referral from primary
      care physicians and other specialists in the surrounding area. The practice incorporated age,
      sex, and gene expression testing into its diagnostic protocol beginning in June 2011. Data
      collection was completed in December 2013. Institutional Review Board (IRB) approval of the
      study protocol was granted by Quorum Review. Informed consent waivers were granted as data
      collection was retrospective and all data were de-identified.
observational model: Case-Control
time perspective: Retrospective
measure: The primary measure of this study is the number of advanced diagnostic tests in ASGES (treatment group) patients compared to the number of advanced diagnostic tests in non-ASGES (control group) patients.
time frame: up to 24 months
description: The primary study endpoint was the percentage of patients for whom advanced diagnostic testing was ordered-stress testing with imaging, computed tomography angiography, or invasive coronary angiography.
arm group label: ASGES (Treatment Group)
description: Patients who received a Corus CAD or Age/Sex/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD
arm group label: Non-ASGES (Control Group)
description: Patients who underwent usual care testing and did not receive a Corus CAD or Age/SEX/Gene Expression Score (ASGES) to aid in the diagnosis of obstructive CAD
intervention type: Diagnostic Test
intervention name: Corus CAD
description: Age/Sex/Gene Expression Score
arm group label: ASGES (Treatment Group)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: David Hoffman, DO
role: Principal Investigator
affiliation: Northeast Ohio Medical University
last name: Lawrence Kline, DP
role: Principal Investigator
affiliation: John C. Lincoln Heart Institute
last name: Jaime Burkle, MD
role: Principal Investigator
affiliation: Piedmont Heart Institute
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Angina Pectoris
mesh term: Chest Pain