<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/NCT01705054</url>
  </required_header>
  <id_info>
    <org_study_id>IN-US-259-0157</org_study_id>
    <nct_id>NCT01705054</nct_id>
  </id_info>
  <brief_title>Angina Prevalence and Provider Evaluation of Angina Relief</brief_title>
  <acronym>APPEAR</acronym>
  <official_title>Angina Prevalence and Provider Evaluation of Angina Relief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Luke's Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Saint Luke's Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is describe the frequency of chest pain and how chest pain impacts&#xD;
      patients' quality of life in the outpatients with chronic coronary artery disease in&#xD;
      contemporary cardiology practice settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goals in the management of stable coronary artery disease (CAD) are to reduce&#xD;
      risk factors for heart attack and to control the symptoms of angina (chest pain). Ideally&#xD;
      angina is well controlled with medications alone, but invasive procedures are a valuable&#xD;
      option for patients with persistent angina. The amount of angina among patients with stable&#xD;
      CAD in the outpatient setting, however, is unknown. An Australian study reported that almost&#xD;
      1 in 3 patients with stable angina being treated by primary care doctors had angina at least&#xD;
      once a week, which was associated with worse quality of life. We propose to examine the&#xD;
      burden of angina in outpatients with stable CAD who are being medically managed by&#xD;
      cardiologists in the United States through administration of a one-time survey. The&#xD;
      information from this study could ultimately help improve management of stable CAD and angina&#xD;
      and illuminate potential underuse of revascularization. While cardiologists are generally&#xD;
      expected to provide better angina control than primary care doctors, establishing the&#xD;
      prevalence of angina among the best providers will help with a framework for interpreting&#xD;
      symptom control among other practitioners.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">July 22, 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seattle Angina Questionnaire</measure>
    <time_frame>One time cardiology office visit.</time_frame>
    <description>Percentage of patients with frequent angina (&gt;1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>One time cardiology office visit.</time_frame>
    <description>Evaluate the impact of frequent angina on Quality of Life (as measured by the SAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician Perspective</measure>
    <time_frame>One time cardiology office visit.</time_frame>
    <description>Identifying differences between patients' and cardiologists' assessment of angina control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiology practices angina control.</measure>
    <time_frame>One time cardiology office visit.</time_frame>
    <description>Evaluate the differences in angina control between cardiology practices.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1246</enrollment>
  <condition>Stable Coronary Artery Disease CAD</condition>
  <arm_group>
    <arm_group_label>Outpatient Coronary Artery Disease Patient</arm_group_label>
    <description>CAD patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatient cardilogy practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Coronary artery disease patients being seen in a participating cardiology office for a&#xD;
             scheduled clinic visit who agree to take the survey.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Too ill to take survey&#xD;
&#xD;
          -  Previously completed this survey&#xD;
&#xD;
          -  Refused to participate&#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>John A Spertus, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Luke's Hospital of Kansas City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Faraz Kureshi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Luke's Hospital of Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Beltrame JF, Weekes AJ, Morgan C, Tavella R, Spertus JA. The prevalence of weekly angina among patients with chronic stable angina in primary care practices: The Coronary Artery Disease in General Practice (CADENCE) Study. Arch Intern Med. 2009 Sep 14;169(16):1491-9. doi: 10.1001/archinternmed.2009.295.</citation>
    <PMID>19752407</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Angina</keyword>
  <keyword>Stable ischemic heart disease</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Seattle Angina Questionnaire (SAQ)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Angina Pectoris</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/NCT01705054
org study id: IN-US-259-0157
nct id: NCT01705054
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is describe the frequency of chest pain and how chest pain impacts
      patients' quality of life in the outpatients with chronic coronary artery disease in
      contemporary cardiology practice settings.
The primary goals in the management of stable coronary artery disease (CAD) are to reduce
      risk factors for heart attack and to control the symptoms of angina (chest pain). Ideally
      angina is well controlled with medications alone, but invasive procedures are a valuable
      option for patients with persistent angina. The amount of angina among patients with stable
      CAD in the outpatient setting, however, is unknown. An Australian study reported that almost
      1 in 3 patients with stable angina being treated by primary care doctors had angina at least
      once a week, which was associated with worse quality of life. We propose to examine the
      burden of angina in outpatients with stable CAD who are being medically managed by
      cardiologists in the United States through administration of a one-time survey. The
      information from this study could ultimately help improve management of stable CAD and angina
      and illuminate potential underuse of revascularization. While cardiologists are generally
      expected to provide better angina control than primary care doctors, establishing the
      prevalence of angina among the best providers will help with a framework for interpreting
      symptom control among other practitioners.
observational model: Case-Only
time perspective: Prospective
measure: Seattle Angina Questionnaire
time frame: One time cardiology office visit.
description: Percentage of patients with frequent angina (>1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ).
measure: Quality of Life
time frame: One time cardiology office visit.
description: Evaluate the impact of frequent angina on Quality of Life (as measured by the SAQ)
measure: Physician Perspective
time frame: One time cardiology office visit.
description: Identifying differences between patients' and cardiologists' assessment of angina control
measure: Cardiology practices angina control.
time frame: One time cardiology office visit.
description: Evaluate the differences in angina control between cardiology practices.
arm group label: Outpatient Coronary Artery Disease Patient
description: CAD patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Spertus, MD, MPH
role: Principal Investigator
affiliation: Saint Luke's Hospital of Kansas City
last name: Faraz Kureshi, MD
role: Principal Investigator
affiliation: Saint Luke's Hospital of Kansas City
facility: 
country: United States
citation: Beltrame JF, Weekes AJ, Morgan C, Tavella R, Spertus JA. The prevalence of weekly angina among patients with chronic stable angina in primary care practices: The Coronary Artery Disease in General Practice (CADENCE) Study. Arch Intern Med. 2009 Sep 14;169(16):1491-9. doi: 10.1001/archinternmed.2009.295.
PMID: 19752407
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Angina Pectoris
sharing ipd: No