<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/NCT01677156</url>
  </required_header>
  <id_info>
    <org_study_id>CDX_000015</org_study_id>
    <secondary_id>PRESET</secondary_id>
    <nct_id>NCT01677156</nct_id>
  </id_info>
  <brief_title>A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (or ASGES) in Primary Care Settings</brief_title>
  <acronym>PRESET</acronym>
  <official_title>The PRESET Registry: A Registry to Evaluate Patterns of Care Associated With the Use of Corus CAD (Age/Sex/Gene Expression Score - ASGES) in Real World Clinical Care Settings</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 PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus&#xD;
      CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings&#xD;
      (PRESET)--was designed as an observational, post-market, real-world registry to evaluate&#xD;
      patterns of care, including referrals to a cardiologist, cardiac stress testing, CT&#xD;
      angiography, within the first month after Corus CAD (ASGES) testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients&#xD;
      presenting with typical or atypical symptoms suggestive of obstructive coronary artery&#xD;
      disease from 21 US primary care practices from August 2012 to August 2014. Demographics,&#xD;
      clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results&#xD;
      (predefined as low [ASGES &lt;15] or elevated [ASGES &gt;15]) were collected, as were referrals to&#xD;
      Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene&#xD;
      Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">713</enrollment>
  <condition>Chest Pain</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Coronary Heart Disease</condition>
  <condition>Angina Pectoris</condition>
  <condition>CAD</condition>
  <condition>CVD</condition>
  <condition>CHD</condition>
  <arm_group>
    <arm_group_label>Receiving Corus CAD (ASGES)</arm_group_label>
    <description>Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CORUS CAD (ASGES)</intervention_name>
    <description>Age/Sex/Gene Expression Score - ASGES</description>
    <arm_group_label>Receiving Corus CAD (ASGES)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to their primary clinician's office with chest pain suggestive of&#xD;
        obstructive coronary artery disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptoms suggestive of CAD, according to the opinion of the site registry clinician&#xD;
&#xD;
          2. Receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD&#xD;
&#xD;
          3. Age &gt;= 18 years&#xD;
&#xD;
          4. Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of myocardial infarction (MI)&#xD;
&#xD;
          2. Current MI or acute coronary syndrome&#xD;
&#xD;
          3. Current New York Heart Association (NYHA) class III or IV congestive heart failure&#xD;
             symptoms&#xD;
&#xD;
          4. Known/documented CAD&#xD;
&#xD;
          5. Diabetes Mellitus&#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>Michael Zapien, MS</last_name>
    <role>Study Director</role>
    <affiliation>CardioDx, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Monane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CardioDx, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Warner Family Practice</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy Health</name>
      <address>
        <city>Hiawassee</city>
        <state>Georgia</state>
        <zip>30546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John's Creek Primary Care</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paul McLaughlin, MD - Family Practice</name>
      <address>
        <city>Mount Sterling</city>
        <state>Kentucky</state>
        <zip>40353</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KD Health and Wellness Center</name>
      <address>
        <city>Simmesport</city>
        <state>Louisiana</state>
        <zip>71369</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctors for Health</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TIMA Wellness</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Internal Medicine</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Medical Center</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bells Medical Clinic</name>
      <address>
        <city>Bells</city>
        <state>Texas</state>
        <zip>75414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Care Clinic</name>
      <address>
        <city>Bonham</city>
        <state>Texas</state>
        <zip>75418</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aldrich Internal Medicine</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Familicare</name>
      <address>
        <city>Hurst</city>
        <state>Texas</state>
        <zip>76054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Clinical+Utility+of+a+Precision+Medicine+Test+Evaluating+Outpatients+with+Suspected+Obstructive+Coronary+Artery+Disease</url>
    <description>Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.</description>
  </link>
  <reference>
    <citation>Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.</citation>
    <PMID>27993573</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASGES</keyword>
  <keyword>Corus CAD</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>Registry</keyword>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Angina Pectoris</keyword>
  <keyword>Chest Pain</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>PRESET</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/NCT01677156
org study id: CDX_000015
secondary id: PRESET
nct id: NCT01677156
lead sponsor: 
has dmc: No
The PRESET Registry--A Registry to Evaluate Patterns of Care Associated With the Use of Corus
      CAD (Age/Sex/Gene Expression score - ASGES) in Real World Clinical Care Settings
      (PRESET)--was designed as an observational, post-market, real-world registry to evaluate
      patterns of care, including referrals to a cardiologist, cardiac stress testing, CT
      angiography, within the first month after Corus CAD (ASGES) testing.
The prospective PRESET Registry (NCT01677156) enrolled stable, nonacute adult patients
      presenting with typical or atypical symptoms suggestive of obstructive coronary artery
      disease from 21 US primary care practices from August 2012 to August 2014. Demographics,
      clinical characteristics, and Corus CAD (Age/Sex/Gene Expression score - ASGES) results
      (predefined as low [ASGES <15] or elevated [ASGES >15]) were collected, as were referrals to
      Cardiology or further functional/anatomic cardiac testing after Corus CAD (Age/Sex/Gene
      Expression score - ASGES) testing. Patients were followed for 1 year post ASGES testing.
observational model: Cohort
time perspective: Prospective
measure: To describe referral patterns for cardiac care and testing within 1 month after gene expression testing.
time frame: 1 month
measure: To describe follow up events (eg., diagnoses, non-cardiac testing, medication use, MACE) at 12 months follow up within ASGES (age, sex,gene expression score) test strata.
time frame: 12 months
arm group label: Receiving Corus CAD (ASGES)
description: Patients receiving Corus CAD (ASGES) to aid in the diagnosis of obstructive CAD
intervention type: Diagnostic Test
intervention name: CORUS CAD (ASGES)
description: Age/Sex/Gene Expression Score - ASGES
arm group label: Receiving Corus CAD (ASGES)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Zapien, MS
role: Study Director
affiliation: CardioDx, Inc.
last name: Mark Monane, MD
role: Principal Investigator
affiliation: CardioDx, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Clinical+Utility+of+a+Precision+Medicine+Test+Evaluating+Outpatients+with+Suspected+Obstructive+Coronary+Artery+Disease
description: Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.
citation: Ladapo JA, Budoff M, Sharp D, Zapien M, Huang L, Maniet B, Herman L, Monane M. Clinical Utility of a Precision Medicine Test Evaluating Outpatients with Suspected Obstructive Coronary Artery Disease. Am J Med. 2017 Apr;130(4):482.e11-482.e17. doi: 10.1016/j.amjmed.2016.11.021. Epub 2016 Dec 16.
PMID: 27993573
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