Chronic Obstructive Pulmonary DiseaseMESA-COPDNCT01397721
Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary
An observational study of Chronic Obstructive Pulmonary Disease, run by Columbia University at 4 sites in United States.
Trial summary
The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early COPD using imaging, gene expression profiling and peripheral cellular measures. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 359 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2009to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately Study Subjects: MESA COPD will recruit approximately 360 participants from EMCAP at Columbia, and from MESA at Columbia; JH University; North Western University; and University of California. Cases will be defined according to the current American Thoracic Society/European Respiratory Society (ATS/ERS) definition of COPD of a post-bronchodilator capacity (FEV1/FVC) ratio < 0.70 and classified as mild, moderate and severe as post-bronchodilator FEV1 of 80-100% predicted, 50-80% predicted and < 50% predicted, respectively. Controls will be defined in the above sampling frame as those with normal lung function (pre-bronchodilator FEV1/FVC ratio >= 0.70, and no restrictive ventilatory defect.
Who may be able to join
- age 50-79 years at time of enrollment
- ever smokers (10 or more pack-years)
- participation in MESA or EMCAP studies
Who cannot join
- clinical cardiovascular disease (left congestive heart failure (CHF), valve disease, coronary artery disease (CAD), stroke, or congenital heart disease),
- asthma, pulmonary embolism or lung disease other than COPD,
- weight > 300 lbs,
- chronic renal insufficiency ([estimated glomerular filtration rate (eGFR)] < 45 mL/min/1.73 m2),
- atrial fibrillation, and
- contraindications to magnetic resonance imagine (MRI), gadolinium, albuterol or spirometry testing.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UCLA Research Center
Alhambra, California, 91801
Johns Hopkins University
Baltimore, Maryland, 21205
Northwestern University Medical School
Chicago, Illinois, 60611
Columbia University
New York, New York, 10032
About this study
Official title: Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary (MESA-COPD)
The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early COPD using imaging, gene expression profiling and peripheral cellular measures.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in the US and will soon replace stroke as the third leading cause.
Translation of promising biological hypotheses of COPD pathogenesis to human populations that may lead to new therapies is urgently needed. The vascular hypothesis of COPD was articulated almost 50 years ago. Bench research on endothelial dysfunction in COPD is evolving rapidly and has shown that acrolein in cigarette smoke causes endothelial apoptosis and endothelial apoptosis is directly implicated in COPD pathogenesis. Clinical studies on endothelial dysfunction and vascular changes in COPD are limited.
The proposed study is a longitudinal study of smokers nested among the MESA-Lung (AAAA7791) and EMphysema and Cancer Action Project (EMCAP) Studies (AAAA6484), which together provide a well-defined cohort of 4,617 participants with prior spirometry and CT measures.
The Multiethnic Study of Atherosclerosis - Chronic Obstructive Pulmonary Disease (MESA COPD Study) has two main scientific purposes:
- characterize the pulmonary vascular changes in COPD and their biology, and
- propose novel pathways for new therapies in COPD.
MESA COPD is a longitudinal study of smokers nested within the MESA-Lung and EMCAP cohorts of 360 participants (160 cases with mild, 60 cases with moderate and 40 cases with severe COPD and 100 controls) who will be phenotyped with magnetic resonance (MR) pulmonary angiography, pulmonary function testing, full-lung CT scans, serum Vascular Endothelial Growth Factor (VEGF), cell assays and gene expression profiling. MESA COPD Study will contribute improving the knowledge of early changes in COPD that may lead to novel disease-modifying medical therapies and preventative strategies.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), pulmonary vasculature, pulmonary hypertension, atherosclerosis, smokers, emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Atherosclerosis, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac structure and pulmonary vascular structure and function
Cardiac structure: changes in right ventricular (RV) mass, RV mass/Right Ventricular End-Diastolic Volume (RV-EDV)
Pulmonary structure: changes in total pulmonary vascular volume (TPVV) and pulmonary artery (PA) perfusion
Function: changes in PA flow and distensibility
Measured: Up to 2 years from start of study
Secondary outcomes (3)
Number of CD31+/CD42 endothelial microparticles (EMPs)
Numbers of CD31+/CD42 EMPs reflective of apoptosis are elevated; They are abnormal in severe, moderate and mild COPD compared to controls.
Measured: Up to 2 years from the start of study
Number of circulating endothelial cells (CEC)
Numbers of circulating endothelial cells (CEC), resulting from endothelial injury, are elevated. They are abnormal in severe, moderate and mild COPD compared to controls
Measured: Up to 2 years from the start of study
Number of endothelial progenitor cells (EPCs), involved in endothelial repair, are decreased
They are abnormal in severe, moderate and mild COPD compared to controls.
Measured: Up to 2 years from the start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMay 2009
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, R. Graham Barr, Columbia University
- Investigators
- R. Graham Barr, MD, DrPh, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397721
- Sponsor's protocol ID
- AAAD6395
- Other IDs
- R01HL093081-01
- Acronym
- MESA-COPD
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2011
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary (MESA-COPD)
- ClinicalTrials.gov ID
- NCT01397721
- Acronym / sponsor ID
- MESA-COPD / AAAD6395
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), pulmonary vasculature, pulmonary hypertension, atherosclerosis, smokers, emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2009 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Multi-Ethnic Study of Atherosclerosis (MESA) - Chronic Obstructive Pulmonary Disease (COPD) Study aims to characterize the pulmonary vascular changes and their biology in early COPD using imaging, gene expression profiling and peripheral cellular measures.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death in the US and will soon replace stroke as the third leading cause.
Translation of promising biological hypotheses of COPD pathogenesis to human populations that may lead to new therapies is urgently needed. The vascular hypothesis of COPD was articulated almost 50 years ago. Bench research on endothelial dysfunction in COPD is evolving rapidly and has shown that acrolein in cigarette smoke causes endothelial apoptosis and endothelial apoptosis is directly implicated in COPD pathogenesis. Clinical studies on endothelial dysfunction and vascular changes in COPD are limited.
The proposed study is a longitudinal study of smokers nested among the MESA-Lung (AAAA7791) and EMphysema and Cancer Action Project (EMCAP) Studies (AAAA6484), which together provide a well-defined cohort of 4,617 participants with prior spirometry and CT measures.
The Multiethnic Study of Atherosclerosis - Chronic Obstructive Pulmonary Disease (MESA COPD Study) has two main scientific purposes:
- characterize the pulmonary vascular changes in COPD and their biology, and
- propose novel pathways for new therapies in COPD.
MESA COPD is a longitudinal study of smokers nested within the MESA-Lung and EMCAP cohorts of 360 participants (160 cases with mild, 60 cases with moderate and 40 cases with severe COPD and 100 controls) who will be phenotyped with magnetic resonance (MR) pulmonary angiography, pulmonary function testing, full-lung CT scans, serum Vascular Endothelial Growth Factor (VEGF), cell assays and gene expression profiling. MESA COPD Study will contribute improving the knowledge of early changes in COPD that may lead to novel disease-modifying medical therapies and preventative strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately Study Subjects: MESA COPD will recruit approximately 360 participants from EMCAP at Columbia, and from MESA at Columbia; JH University; North Western University; and University of California. Cases will be defined according to the current American Thoracic Society/European Respiratory Society (ATS/ERS) definition of COPD of a post-bronchodilator capacity (FEV1/FVC) ratio < 0.70 and classified as mild, moderate and severe as post-bronchodilator FEV1 of 80-100% predicted, 50-80% predicted and < 50% predicted, respectively. Controls will be defined in the above sampling frame as those with normal lung function (pre-bronchodilator FEV1/FVC ratio >= 0.70, and no restrictive ventilatory defect.
Key inclusion criteria (3 listed)
- age 50-79 years at time of enrollment
- ever smokers (10 or more pack-years)
- participation in MESA or EMCAP studies
Key exclusion criteria (6 listed)
- clinical cardiovascular disease (left congestive heart failure (CHF), valve disease, coronary artery disease (CAD), stroke, or congenital heart disease),
- asthma, pulmonary embolism or lung disease other than COPD,
- weight > 300 lbs,
- chronic renal insufficiency ([estimated glomerular filtration rate (eGFR)] < 45 mL/min/1.73 m2),
- atrial fibrillation, and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cardiac structure and pulmonary vascular structure and function
Time frame: Up to 2 years from start of study
Cardiac structure: changes in right ventricular (RV) mass, RV mass/Right Ventricular End-Diastolic Volume (RV-EDV) Pulmonary structure: changes in total pulmonary vascular volume (TPVV) and pulmonary artery (PA) perfusion Function: changes in PA flow and distensibility
3 secondary outcomes
Number of CD31+/CD42 endothelial microparticles (EMPs)
Time frame: Up to 2 years from the start of study
Number of circulating endothelial cells (CEC)
Time frame: Up to 2 years from the start of study
Number of endothelial progenitor cells (EPCs), involved in endothelial repair, are decreased
Time frame: Up to 2 years from the start of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Related InfoLink provided by the sponsor.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Graham Barr, MD, DrPh principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Columbia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac structure and pulmonary vascular structure and function (time frame: Up to 2 years from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.