<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/NCT02245178</url>
  </required_header>
  <id_info>
    <org_study_id>STU00090966</org_study_id>
    <secondary_id>R01HL122477</secondary_id>
    <nct_id>NCT02245178</nct_id>
  </id_info>
  <brief_title>Lung Function Decline and Disease Risk From Young Adulthood to Middle Age</brief_title>
  <acronym>CARDIA Lung</acronym>
  <official_title>Lung Function Decline and Disease Risk From Young Adulthood to Middle Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Foundation Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the&#xD;
      United States, but markers that predict risk of developing disease outside of cigarette&#xD;
      smoking have not been identified. Individuals with lung disease frequently have concurrent&#xD;
      cardiovascular disease, but the reason for this is not well understood. In this study, we&#xD;
      will identify markers that predict risk of future lung disease and evaluate the concurrent&#xD;
      subclinical evolution of lung and heart dysfunction. This will allow for targeting of&#xD;
      preventive strategies to stop the rising incidence of COPD and other lung diseases and&#xD;
      provide insights into why heart and lung disease frequently occur together.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the&#xD;
      United States. Although smoking is a major risk factor for COPD, only a minority of smokers&#xD;
      develops COPD. Markers that predict risk of future COPD in young adults would be valuable to&#xD;
      target risk reduction strategies and identify subclinical disease. Although COPD is&#xD;
      classically defined by obstructive lung physiology, many individuals, including smokers, have&#xD;
      spirometric restrictive physiology. Reduced lung function, whether manifesting as COPD or&#xD;
      restriction, is associated with adverse cardiovascular outcomes. Our long-term goals are to&#xD;
      identify subclinical manifestations of COPD and other lung disease and explore why heart and&#xD;
      lung disease co-exist. This is an ancillary study to the Coronary Artery Risk Development in&#xD;
      Young Adults (CARDIA) cohort study's year 30 examination. We will add pre- and&#xD;
      post-bronchodilator spirometry to the exam and evaluate the lung parenchymal and vascular&#xD;
      structure on cardiac CT scans from year 25. Informed by our preliminary data which documents&#xD;
      that markers of systemic inflammation and endothelial dysfunction are associated with&#xD;
      subsequent lung function decline in young adults, that lung function decline in young adults&#xD;
      is associated with incident hypertension, and that there is a divergence in cardiac structure&#xD;
      and function depending on the pattern of lung function decline, we propose the following&#xD;
      specific aims: (1) To evaluate factors in young adults that predict incident COPD and/or&#xD;
      restriction; (2) To determine whether incident COPD and incident restriction are associated&#xD;
      with distinct cardiac structural and functional changes; and (3) To determine the lung&#xD;
      structural and intrathoracic vascular changes associated with incident COPD and incident&#xD;
      restriction. We will test the hypothesis that early life markers of systemic inflammation and&#xD;
      endothelial dysfunction are associated with risk of subsequent lung disease and explore&#xD;
      whether different inflammatory markers predict different lung phenotypes. We will then&#xD;
      evaluate the cardiac structural changes associated with different lung phenotypes and&#xD;
      evaluate the lung structural and pulmonary vascular alterations that may explain the&#xD;
      concurrently evolving cardiovascular findings associated with developing lung disease. These&#xD;
      studies will describe the subclinical manifestations of lung disease, identify markers that&#xD;
      predict risk of future lung disease, and expand our understanding of heart-lung interactions&#xD;
      as they evolve from health in young adults to disease in middle age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Incident COPD</measure>
    <time_frame>30 years</time_frame>
    <description>From cohort initiation, predictors of incident COPD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incident restriction</measure>
    <time_frame>30 years</time_frame>
    <description>From cohort initiation, predictors of incident restrictive lung physiology</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3193</enrollment>
  <condition>COPD</condition>
  <condition>Lung Function</condition>
  <condition>Heart - Lung Interaction</condition>
  <condition>Restrictive Lung Disease</condition>
  <arm_group>
    <arm_group_label>Obervational - CARDIA participants</arm_group_label>
    <description>CARDIA study participants will undergo lung function testing and have existing thoracic CT scans analyzed for lung structure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung spirometry</intervention_name>
    <description>measurement of pulmonary function pre- and post-bronchodilator</description>
    <arm_group_label>Obervational - CARDIA participants</arm_group_label>
    <other_name>lung function</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT scan analysis</intervention_name>
    <description>Analysis of existing year 25 thoracic CT scans for lung and intrathoracic vascular structure</description>
    <arm_group_label>Obervational - CARDIA participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in the main Coronary Artery Risk Development in Young Adults (CARDIA) cohort&#xD;
        study attending the year 30 examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the main CARDIA examination at year 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shortness of breath with pain in the chest within the past week&#xD;
&#xD;
          -  Heart attack or stroke within the past month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Kalhan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Ravi Kalhan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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/NCT02245178
org study id: STU00090966
secondary id: R01HL122477
nct id: NCT02245178
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the
      United States, but markers that predict risk of developing disease outside of cigarette
      smoking have not been identified. Individuals with lung disease frequently have concurrent
      cardiovascular disease, but the reason for this is not well understood. In this study, we
      will identify markers that predict risk of future lung disease and evaluate the concurrent
      subclinical evolution of lung and heart dysfunction. This will allow for targeting of
      preventive strategies to stop the rising incidence of COPD and other lung diseases and
      provide insights into why heart and lung disease frequently occur together.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the
      United States. Although smoking is a major risk factor for COPD, only a minority of smokers
      develops COPD. Markers that predict risk of future COPD in young adults would be valuable to
      target risk reduction strategies and identify subclinical disease. Although COPD is
      classically defined by obstructive lung physiology, many individuals, including smokers, have
      spirometric restrictive physiology. Reduced lung function, whether manifesting as COPD or
      restriction, is associated with adverse cardiovascular outcomes. Our long-term goals are to
      identify subclinical manifestations of COPD and other lung disease and explore why heart and
      lung disease co-exist. This is an ancillary study to the Coronary Artery Risk Development in
      Young Adults (CARDIA) cohort study's year 30 examination. We will add pre- and
      post-bronchodilator spirometry to the exam and evaluate the lung parenchymal and vascular
      structure on cardiac CT scans from year 25. Informed by our preliminary data which documents
      that markers of systemic inflammation and endothelial dysfunction are associated with
      subsequent lung function decline in young adults, that lung function decline in young adults
      is associated with incident hypertension, and that there is a divergence in cardiac structure
      and function depending on the pattern of lung function decline, we propose the following
      specific aims: (1) To evaluate factors in young adults that predict incident COPD and/or
      restriction; (2) To determine whether incident COPD and incident restriction are associated
      with distinct cardiac structural and functional changes; and (3) To determine the lung
      structural and intrathoracic vascular changes associated with incident COPD and incident
      restriction. We will test the hypothesis that early life markers of systemic inflammation and
      endothelial dysfunction are associated with risk of subsequent lung disease and explore
      whether different inflammatory markers predict different lung phenotypes. We will then
      evaluate the cardiac structural changes associated with different lung phenotypes and
      evaluate the lung structural and pulmonary vascular alterations that may explain the
      concurrently evolving cardiovascular findings associated with developing lung disease. These
      studies will describe the subclinical manifestations of lung disease, identify markers that
      predict risk of future lung disease, and expand our understanding of heart-lung interactions
      as they evolve from health in young adults to disease in middle age.
observational model: Cohort
time perspective: Prospective
measure: Incident COPD
time frame: 30 years
description: From cohort initiation, predictors of incident COPD
measure: Incident restriction
time frame: 30 years
description: From cohort initiation, predictors of incident restrictive lung physiology
arm group label: Obervational - CARDIA participants
description: CARDIA study participants will undergo lung function testing and have existing thoracic CT scans analyzed for lung structure.
intervention type: Procedure
intervention name: Lung spirometry
description: measurement of pulmonary function pre- and post-bronchodilator
arm group label: Obervational - CARDIA participants
other name: lung function
intervention type: Other
intervention name: CT scan analysis
description: Analysis of existing year 25 thoracic CT scans for lung and intrathoracic vascular structure
arm group label: Obervational - CARDIA participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 48 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ravi Kalhan, MD
role: Principal Investigator
affiliation: Northwestern University
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Ravi Kalhan
investigator title: Associate Professor
mesh term: Lung Diseases