<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/NCT01734629</url>
  </required_header>
  <id_info>
    <org_study_id>2011/02814-0 FAPESP</org_study_id>
    <secondary_id>0503/11</secondary_id>
    <nct_id>NCT01734629</nct_id>
  </id_info>
  <brief_title>Pulmonary Disease in Patients Referred for Coronary CT</brief_title>
  <official_title>Pulmonary Disease in Patients Referred for Coronary CT and Association Between Spirometric Abnormalities and Coronary Calcium Score.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies show an association between chronic obstructive pulmonary disease (COPD) and&#xD;
      coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with&#xD;
      physical inactivity, advanced age and systemic inflammation The use of coronary computed&#xD;
      tomography (CCT) with multiple detectors is a diagnostic method for coronary disease,&#xD;
      describing the anatomy and severity of arterial obstruction. One way of estimating the&#xD;
      cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and&#xD;
      CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.&#xD;
&#xD;
      The aim of this observational study is to establish the correlation between the CCS and lung&#xD;
      function. It will also correlate the presence of irreversible airway obstruction with&#xD;
      significant coronary lesions.&#xD;
&#xD;
      Patients over 40 years referred to CCT who agree to participate in the study will perform a&#xD;
      spirometry with bronchodilator and collect a blood sample to measure serum markers of&#xD;
      inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP),&#xD;
      tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the&#xD;
      general population and in subgroups: smokers, former smokers and nonsmokers.&#xD;
&#xD;
      One year after the CCT patients will be contacted by the investigators and accessed for&#xD;
      emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory&#xD;
      events.&#xD;
&#xD;
      The investigators hypothesis is that reduced lung function is independently associated with&#xD;
      elevated CCS and is, also a risk factor for increased hospital admission and coronary events.&#xD;
&#xD;
      The concomitant assessment of lung function and CCS can contribute knowledge about the&#xD;
      epidemiological association between pulmonary disease and CAD. This can also add to evidence&#xD;
      for the use of spirometry as a marker of cardiovascular risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Coronary Calcium Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coronary obstruction on CT</measure>
    <time_frame>Baseline</time_frame>
    <description>Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admissions</measure>
    <time_frame>1 year</time_frame>
    <description>Hospital admissions will be accessed after one year from enrollment and compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ER visits</measure>
    <time_frame>1 year</time_frame>
    <description>ER visits will be accessed after one year from enrollment and compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatal and non fatal cardiac or respiratory events</measure>
    <time_frame>1 year</time_frame>
    <description>Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Smoking Status</measure>
    <time_frame>1 year</time_frame>
    <description>All endpoints will be evaluated in smoking and nonsmoking subgroups.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">205</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Atheroscleroses</condition>
  <condition>COPD</condition>
  <condition>Respiratory Diseases</condition>
  <arm_group>
    <arm_group_label>Coronary CT Spirometry Cohort</arm_group_label>
    <description>Patients refereed to coronary CT enrolled in the study.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 40 years old refereed to coronary CT in the investigator´s institution.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for coronary CT.&#xD;
&#xD;
          -  Age greater than 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of myocardial revascularization (surgical or percutaneous)&#xD;
&#xD;
          -  Cognitive-functional incapacity to perform spirometry&#xD;
&#xD;
          -  Contraindication for administration of 400 mcg of albuterol&#xD;
&#xD;
          -  Acute myocardial infarction or unstable angina within 2 weeks&#xD;
&#xD;
          -  Angina pectoris class III or IV according to the Canadian Cardiovascular Society&#xD;
&#xD;
          -  Heart failure New York Heart Association class III or IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alberto Cukier, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Incor - HCFMUSP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Disease</keyword>
  <keyword>COPD</keyword>
  <keyword>Spirometry</keyword>
  <keyword>Coronary tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Atherosclerosis</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/NCT01734629
org study id: 2011/02814-0 FAPESP
secondary id: 0503/11
nct id: NCT01734629
lead sponsor: 
has dmc: Yes
Several studies show an association between chronic obstructive pulmonary disease (COPD) and
      coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with
      physical inactivity, advanced age and systemic inflammation The use of coronary computed
      tomography (CCT) with multiple detectors is a diagnostic method for coronary disease,
      describing the anatomy and severity of arterial obstruction. One way of estimating the
      cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and
      CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.

      The aim of this observational study is to establish the correlation between the CCS and lung
      function. It will also correlate the presence of irreversible airway obstruction with
      significant coronary lesions.

      Patients over 40 years referred to CCT who agree to participate in the study will perform a
      spirometry with bronchodilator and collect a blood sample to measure serum markers of
      inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP),
      tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the
      general population and in subgroups: smokers, former smokers and nonsmokers.

      One year after the CCT patients will be contacted by the investigators and accessed for
      emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory
      events.

      The investigators hypothesis is that reduced lung function is independently associated with
      elevated CCS and is, also a risk factor for increased hospital admission and coronary events.

      The concomitant assessment of lung function and CCS can contribute knowledge about the
      epidemiological association between pulmonary disease and CAD. This can also add to evidence
      for the use of spirometry as a marker of cardiovascular risk.
observational model: Cohort
time perspective: Prospective
measure: Coronary Calcium Score
time frame: Baseline
description: Coronary calcium score is a measurement obtained in coronary computer tomography. The results will be compared between group with and without spirometric abnormalities.
measure: Coronary obstruction on CT
time frame: Baseline
description: Presence or absence of coronary obstruction and it´s quantification by Duke score will be compared between group with and without spirometric abnormality.
measure: Hospital Admissions
time frame: 1 year
description: Hospital admissions will be accessed after one year from enrollment and compared between groups
measure: ER visits
time frame: 1 year
description: ER visits will be accessed after one year from enrollment and compared between groups
measure: Fatal and non fatal cardiac or respiratory events
time frame: 1 year
description: Fatal and non fatal cardiac or respiratory events will be accessed after one year from enrollment and compared between groups
measure: Smoking Status
time frame: 1 year
description: All endpoints will be evaluated in smoking and nonsmoking subgroups.
arm group label: Coronary CT Spirometry Cohort
description: Patients refereed to coronary CT enrolled in the study.
Blood Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Alberto Cukier, MD PHD
role: Principal Investigator
affiliation: Incor - HCFMUSP
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis