<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/NCT03269721</url>
  </required_header>
  <id_info>
    <org_study_id>201404738</org_study_id>
    <secondary_id>1R01HL134822-01</secondary_id>
    <nct_id>NCT03269721</nct_id>
  </id_info>
  <brief_title>COPD-Related Physiology and the Brain</brief_title>
  <official_title>Determinants of Altered Brain Structure and Function in Smokers With COPD-Related Lung Pathophysiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karin Hoth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</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>
      COPD is the third leading cause of combined morbidity, disability, and mortality in the&#xD;
      United States and is often associated with cognitive impairment. The goal of the proposed&#xD;
      project is to examine novel pulmonary and vascular physiological mechanisms that contribute&#xD;
      to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The&#xD;
      project will generate information to ultimately inform the development of interventions to&#xD;
      delay or prevent cognitive dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of morbidity and&#xD;
      mortality in the US with increasing prevalence in older adults. The impact of COPD on the&#xD;
      brain is an area of expanding research interest. A staggering 40-60% of patients with COPD&#xD;
      have cognitive impairments including deficits in executive functioning (e.g., decision&#xD;
      making), processing speed, and memory. Intact cognition is critical for independently&#xD;
      managing daily tasks (e.g., medication and money management). Since there are currently no&#xD;
      treatments to fully reverse cognitive impairment once it is present, preventing and delaying&#xD;
      onset is essential. Given the high prevalence of COPD, understanding how COPD confers an&#xD;
      increased risk for cognitive impairment should be a top public health priority. There is an&#xD;
      urgent need to identify potentially modifiable physiological characteristics of individuals&#xD;
      with early COPD-related pathophysiology who are at risk of developing brain abnormalities.&#xD;
      The earliest changes that occur in COPD are driven by an enhanced chronic inflammatory&#xD;
      response that includes small airway disease in the lung and vascular abnormalities.&#xD;
      COPD-related lung pathophysiology can be measured continuously and is separable from amount&#xD;
      of smoking. These physiological changes are often present in individuals who do not meet&#xD;
      traditional criteria for COPD diagnosis and have not yet manifested significant clinical&#xD;
      symptoms. We propose that chronic smokers who are susceptible to COPD and show evidence of&#xD;
      COPD-related lung pathophysiology on lung CT also experience vascular dysfunction&#xD;
      (particularly central artery stiffness) that contributes to structural brain abnormalities&#xD;
      and cognitive impairment. The proposed project will: 1) model the effects of novel&#xD;
      physiological mechanisms on the brain in COPD, 2) focus on changes in brain structure and&#xD;
      function early in the development of COPD by including smokers who have evidence of early&#xD;
      COPD-related lung pathophysiology but do not meet traditional criteria for COPD, and 3)&#xD;
      utilize advanced technology to assess the lung (lung CT) and brain (MRI). We will recruit&#xD;
      participants with existing lung CT from ongoing NIH projects to complete pulmonary and&#xD;
      vascular measures, cognitive assessment, and brain MRI. The project is highly&#xD;
      multidisciplinary and leverages unique resources at the University of Iowa including the&#xD;
      Institute for Clinical and Translational Science, the Translational Human Vascular Physiology&#xD;
      Lab, the Iowa Neuroimaging Consortium, and the Iowa Comprehensive Lung Imaging Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>White matter (WM) structural integrity from brain magnetic resonance imaging (MRI)</measure>
    <time_frame>At the end of data collection in 2024</time_frame>
    <description>Fractional anisotropy from diffusion weighted imaging will be the primary WM measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropsychological test performance: average executive functioning-processing speed domain summary score</measure>
    <time_frame>At the end of data collection in 2024</time_frame>
    <description>The domain summary score represents the average of the norm referenced standardized scores for the following measures: Trail Making Test Part B, Controlled Oral Word Association, Stroop Color Word Test Interference Score, and WAIS-IV (Wechsler Adult Intelligence Scale IV) Coding</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">275</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive (COPD)</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Never Smoker</arm_group_label>
    <description>Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <description>Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
    <description>Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neuropsychological Assessment</intervention_name>
    <description>Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spirometry</intervention_name>
    <description>Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arterial Blood Gas</intervention_name>
    <description>Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diffusion Capacity of the Lung for Carbon Monoxide</intervention_name>
    <description>For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
    <other_name>(DLCO)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>6 Minute Walk Test</intervention_name>
    <description>Distance walked in 6 minutes will be the primary outcome.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
    <other_name>6MWT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Systemic Vascular Measures</intervention_name>
    <description>Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood Biomarkers</intervention_name>
    <description>High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Symptom Questionnaire Measures</intervention_name>
    <description>M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brain MRI</intervention_name>
    <description>Primary neuroimaging outcomes of interest are white matter structural integrity</description>
    <arm_group_label>Never Smoker</arm_group_label>
    <arm_group_label>Smoker/Past smoker-No Airflow Limitation</arm_group_label>
    <arm_group_label>Smoker/Past smoker-W/Airflow Limitation</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stored blood samples may be used to evaluate additional biomarkers. These future studies may&#xD;
      provide additional information that will be helpful in understanding COPD and its&#xD;
      comorbidities. If consent is given, samples may also be used for potential genetic research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from the Iowa COPD research registry, which includes&#xD;
        participants from several NIH funded studies with quantitative lung imaging obtained in the&#xD;
        Iowa Comprehensive Lung Imaging Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 30-85, &gt; 8th grade education, Normal/corrected hearing and vision, English Speaker,&#xD;
        Ability to comfortably lie flat for 1 hour.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Other concomitant respiratory disorder other than asthma (e.g., cystic fibrosis), Use of&#xD;
        antibiotics or steroids for a COPD exacerbation within the past month, Use of 24-hour&#xD;
        oxygen, Pregnancy or suspected pregnancy, Uncontrolled cancer within the last 5 years,&#xD;
        Radiation therapy to the chest, Lung surgery (LVRS, transplant, lobectomy), Lung cancer&#xD;
        known or suspected, Eye surgery in the last 3 months, Pulmonary Hypertension,&#xD;
        Insulin-dependent diabetes, Inability to use albuterol, Chest or abdominal surgery in the&#xD;
        past 3 months, Heart attack in the last 3 months, Hospitalization for any heart problem in&#xD;
        the past month, Prior neurological condition (e.g., stroke, epilepsy, head injury with &gt;15&#xD;
        mins. loss of consciousness), Previous diagnosis of dementia or learning disability, Major&#xD;
        comorbid medical conditions with known cognitive effects (e.g., renal failure, HF),&#xD;
        Psychotic disorder, bipolar disorder, current substance use disorder other than tobacco&#xD;
        use, Change in psychiatric medication in last month, Claustrophobia, Metal object in body&#xD;
        that may interfere with neuroimaging.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karin F Hoth, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa Department of Psychiatry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carinda J Linkenmeyer, MA</last_name>
    <phone>319-353-8520</phone>
    <email>carinda-linkenmeyer@uiowa.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Carinda Linkenmeyer</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carinda J Linkenmeyer, M.A.</last_name>
      <phone>319-353-8520</phone>
      <email>carinda-linkenmeyer@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Karin F Hoth, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gary L Pierce, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alejandro Comella, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John D Newell, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peggy Nopoulos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent A Magnotta, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric Hoffman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Karin Hoth</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cognition</keyword>
  <keyword>Pulmonary</keyword>
  <keyword>COPD</keyword>
  <keyword>Lung</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbon Monoxide</mesh_term>
  </intervention_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/NCT03269721
org study id: 201404738
secondary id: 1R01HL134822-01
nct id: NCT03269721
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
COPD is the third leading cause of combined morbidity, disability, and mortality in the
      United States and is often associated with cognitive impairment. The goal of the proposed
      project is to examine novel pulmonary and vascular physiological mechanisms that contribute
      to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The
      project will generate information to ultimately inform the development of interventions to
      delay or prevent cognitive dysfunction.
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of morbidity and
      mortality in the US with increasing prevalence in older adults. The impact of COPD on the
      brain is an area of expanding research interest. A staggering 40-60% of patients with COPD
      have cognitive impairments including deficits in executive functioning (e.g., decision
      making), processing speed, and memory. Intact cognition is critical for independently
      managing daily tasks (e.g., medication and money management). Since there are currently no
      treatments to fully reverse cognitive impairment once it is present, preventing and delaying
      onset is essential. Given the high prevalence of COPD, understanding how COPD confers an
      increased risk for cognitive impairment should be a top public health priority. There is an
      urgent need to identify potentially modifiable physiological characteristics of individuals
      with early COPD-related pathophysiology who are at risk of developing brain abnormalities.
      The earliest changes that occur in COPD are driven by an enhanced chronic inflammatory
      response that includes small airway disease in the lung and vascular abnormalities.
      COPD-related lung pathophysiology can be measured continuously and is separable from amount
      of smoking. These physiological changes are often present in individuals who do not meet
      traditional criteria for COPD diagnosis and have not yet manifested significant clinical
      symptoms. We propose that chronic smokers who are susceptible to COPD and show evidence of
      COPD-related lung pathophysiology on lung CT also experience vascular dysfunction
      (particularly central artery stiffness) that contributes to structural brain abnormalities
      and cognitive impairment. The proposed project will: 1) model the effects of novel
      physiological mechanisms on the brain in COPD, 2) focus on changes in brain structure and
      function early in the development of COPD by including smokers who have evidence of early
      COPD-related lung pathophysiology but do not meet traditional criteria for COPD, and 3)
      utilize advanced technology to assess the lung (lung CT) and brain (MRI). We will recruit
      participants with existing lung CT from ongoing NIH projects to complete pulmonary and
      vascular measures, cognitive assessment, and brain MRI. The project is highly
      multidisciplinary and leverages unique resources at the University of Iowa including the
      Institute for Clinical and Translational Science, the Translational Human Vascular Physiology
      Lab, the Iowa Neuroimaging Consortium, and the Iowa Comprehensive Lung Imaging Center.
observational model: Cohort
time perspective: Prospective
measure: White matter (WM) structural integrity from brain magnetic resonance imaging (MRI)
time frame: At the end of data collection in 2024
description: Fractional anisotropy from diffusion weighted imaging will be the primary WM measure
measure: Neuropsychological test performance: average executive functioning-processing speed domain summary score
time frame: At the end of data collection in 2024
description: The domain summary score represents the average of the norm referenced standardized scores for the following measures: Trail Making Test Part B, Controlled Oral Word Association, Stroop Color Word Test Interference Score, and WAIS-IV (Wechsler Adult Intelligence Scale IV) Coding
arm group label: Never Smoker
description: Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI
arm group label: Smoker/Past smoker-No Airflow Limitation
description: Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI
arm group label: Smoker/Past smoker-W/Airflow Limitation
description: Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI
intervention type: Behavioral
intervention name: Neuropsychological Assessment
description: Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Procedure
intervention name: Spirometry
description: Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Procedure
intervention name: Arterial Blood Gas
description: Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Procedure
intervention name: Diffusion Capacity of the Lung for Carbon Monoxide
description: For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
other name: (DLCO)
intervention type: Diagnostic Test
intervention name: 6 Minute Walk Test
description: Distance walked in 6 minutes will be the primary outcome.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
other name: 6MWT
intervention type: Procedure
intervention name: Systemic Vascular Measures
description: Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Biological
intervention name: Blood Biomarkers
description: High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Behavioral
intervention name: Symptom Questionnaire Measures
description: M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
intervention type: Procedure
intervention name: Brain MRI
description: Primary neuroimaging outcomes of interest are white matter structural integrity
arm group label: Never Smoker
arm group label: Smoker/Past smoker-No Airflow Limitation
arm group label: Smoker/Past smoker-W/Airflow Limitation
Stored blood samples may be used to evaluate additional biomarkers. These future studies may
      provide additional information that will be helpful in understanding COPD and its
      comorbidities. If consent is given, samples may also be used for potential genetic research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karin F Hoth, PhD
role: Principal Investigator
affiliation: University of Iowa Department of Psychiatry
last name: Carinda J Linkenmeyer, MA
phone: 319-353-8520
email: carinda-linkenmeyer@uiowa.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Karin Hoth
investigator title: Associate Professor
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Carbon Monoxide
sharing ipd: No