<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/NCT03235622</url>
  </required_header>
  <id_info>
    <org_study_id>B-1707-406-102</org_study_id>
    <nct_id>NCT03235622</nct_id>
  </id_info>
  <brief_title>Women Health Cohort for Breast, Bone and Coronary Artery Disease</brief_title>
  <acronym>BBC</acronym>
  <official_title>Women Health Cohort for Breast, Bone and Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single center cohort which enrolled women who performed mammography, bone densitometry&#xD;
      (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March&#xD;
      2011 to February 2013.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate whether bone mineral density and breast arterial calcification can predict&#xD;
      coronary artery disease in women older than 40 years&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2011</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Presence of coronary plaque</measure>
    <time_frame>5 years</time_frame>
    <description>Any coronary plaque in coronary CT angiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of coronary plaque</measure>
    <time_frame>5 years</time_frame>
    <description>Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>5 years</time_frame>
    <description>Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization</description>
  </secondary_outcome>
  <enrollment type="Actual">2100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Coronary CT angiography</intervention_name>
    <description>Presence of coronary plaques Characteristic of coronary plaques</description>
    <other_name>Bone DEXA</other_name>
    <other_name>Mammography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  The number of women who met inclusion criteria was 2113.&#xD;
&#xD;
          -  13 women were excluded due to history of coronary revascularization (n=1) and breast&#xD;
             surgery or intervention (n=12).&#xD;
&#xD;
          -  Finally, 2100 women were enrolled to the BBC cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women (≥ 40 years) who performed mammography, bone DEXA, and coronary CT angiography&#xD;
             at health promotion center of Seoul National University Bundang Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who have history of breast surgery or intervention&#xD;
&#xD;
          -  Women who have history of myocardial infarction or revascularization&#xD;
&#xD;
          -  Too poor image quality of coronary CT angiography for interpretation&#xD;
&#xD;
          -  Renal dysfunction with serum creatinine ≥ 1.4mg/dL&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung-Won Suh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 29, 2017</last_update_submitted>
  <last_update_submitted_qc>July 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jung-Won Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>Undecided</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/NCT03235622
org study id: B-1707-406-102
nct id: NCT03235622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A single center cohort which enrolled women who performed mammography, bone densitometry
      (DEXA), and coronary CT angiography in Seoul National University Bundang Hospital from March
      2011 to February 2013.
To evaluate whether bone mineral density and breast arterial calcification can predict
      coronary artery disease in women older than 40 years
observational model: Cohort
time perspective: Retrospective
measure: Presence of coronary plaque
time frame: 5 years
description: Any coronary plaque in coronary CT angiography
measure: Characteristics of coronary plaque
time frame: 5 years
description: Plaque characteristics (fibrosis, calcification, lipid, thrombosis) in coronary CT angiography
measure: Major adverse cardiovascular events
time frame: 5 years
description: Cardiac death, nonfatal myocardial infarction, ischemic stroke, coronary revascularization
intervention type: Diagnostic Test
intervention name: Coronary CT angiography
description: Presence of coronary plaques Characteristic of coronary plaques
other name: Bone DEXA
other name: Mammography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jung-Won Suh, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jung-Won Suh
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided