COPD-Related Physiology and the Brain
Determinants of Altered Brain Structure and Function in Smokers With COPD-Related Lung Pathophysiology
2 other identifiers
observational
170
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedDecember 24, 2025
December 1, 2025
8 years
August 30, 2017
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
White matter (WM) structural integrity from brain magnetic resonance imaging (MRI)
Fractional anisotropy from diffusion weighted imaging will be the primary WM measure
At the end of data collection in 2024
Neuropsychological test performance: average executive functioning-processing speed domain summary score
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
At the end of data collection in 2024
Study Arms (3)
Never Smoker
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
Smoker/Past smoker-No Airflow Limitation
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
Smoker/Past smoker-W/Airflow Limitation
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
Interventions
Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.
Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.
Distance walked in 6 minutes will be the primary outcome.
Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.
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.
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
Primary neuroimaging outcomes of interest are white matter structural integrity
Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention
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.
Eligibility Criteria
Participants will be recruited from the Iowa COPD research registry, which includes participants from several NIH funded studies with quantitative lung imaging obtained in the Iowa Comprehensive Lung Imaging Center.
You may qualify if:
- Age 30-85, \> 8th grade education, Normal/corrected hearing and vision, English Speaker, Ability to comfortably lie flat for 1 hour.
You may not qualify if:
- Other concomitant respiratory disorder other than asthma (e.g., cystic fibrosis), Use of antibiotics or steroids for a COPD exacerbation within the past month, Use of 24-hour oxygen, Pregnancy or suspected pregnancy, Uncontrolled cancer within the last 5 years, Radiation therapy to the chest, Lung surgery (LVRS, transplant, lobectomy), Lung cancer known or suspected, Eye surgery in the last 3 months, Pulmonary Hypertension, Insulin-dependent diabetes, Inability to use albuterol, Chest or abdominal surgery in the past 3 months, Heart attack in the last 3 months, Hospitalization for any heart problem in the past month, Prior neurological condition (e.g., stroke, epilepsy, head injury with \>15 mins. loss of consciousness), Previous diagnosis of dementia or learning disability, Major comorbid medical conditions with known cognitive effects (e.g., renal failure, HF), Psychotic disorder, bipolar disorder, current substance use disorder other than tobacco use, Change in psychiatric medication in last month, Claustrophobia, Metal object in body that may interfere with neuroimaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karin Hothlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Iowa
Iowa City, Iowa, 52242, United States
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin F Hoth, PhD
University of Iowa Department of Psychiatry
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 30, 2017
First Posted
September 1, 2017
Study Start
May 1, 2017
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share