Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary

NCT ID: NCT01397721

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2018-04-30

Brief Summary

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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

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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:

1. characterize the pulmonary vascular changes in COPD and their biology, and
2. 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

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age 50-79 years at time of enrollment
* ever smokers (10 or more pack-years)
* participation in MESA or EMCAP studies

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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R. Graham Barr

Irving Associate Professor of Medicine and Associate Professor of Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R. Graham Barr, MD, DrPh

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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UCLA Research Center

Alhambra, California, United States

Site Status

Northwestern University Medical School

Chicago, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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R01HL093081-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAD6395

Identifier Type: -

Identifier Source: org_study_id

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