Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary (MESA-COPD)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
R. Graham Barr, Columbia University
ClinicalTrials.gov Identifier:
First received: July 13, 2011
Last updated: April 22, 2015
Last verified: April 2015

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.

Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pulmonary Vascular Changes in Early Chronic Obstructive Pulmonary (MESA-COPD)

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Changes in cardiac structure and pulmonary vascular structure and function [ Time Frame: Up to 2 years from start of study ] [ Designated as safety issue: No ]

    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

Secondary Outcome Measures:
  • Numbers of CD31+/CD42 endothelial microparticles (EMPs) [ Time Frame: Up to 2 years from the start of study ] [ Designated as safety issue: No ]
    Numbers of CD31+/CD42 EMPs reflective of apoptosis are elevated; They are abnormal in severe, moderate and mild COPD compared to controls.

  • Numbers of circulating endothelial cells (CEC) [ Time Frame: Up to 2 years from the start of study ] [ Designated as safety issue: No ]
    Numbers of circulating endothelial cells (CEC), resulting from endothelial injury, are elevated. They are abnormal in severe, moderate and mild COPD compared to controls

  • Numbers of endothelial progenitor cells (EPCs), involved in endothelial repair, are decreased [ Time Frame: Up to 2 years from the start of study ] [ Designated as safety issue: No ]
    They are abnormal in severe, moderate and mild COPD compared to controls.

Biospecimen Retention:   Samples With DNA

Blood will be stored at Columbia and at University of Vermont, identified only by study ID and following standard procedures. It will be accessible only to study investigators and, if the participant approves, outside investigators following MESA/NIH protocols and with IRB approval. Blood will be kept indefinitely.

Enrollment: 360
Study Start Date: May 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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:

  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.


Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.


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),
  • cancer,
  • atrial fibrillation, and
  • contraindications to magnetic resonance imagine (MRI), gadolinium, albuterol or spirometry testing.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01397721

United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: R. Graham Barr, M.D., Dr.PH. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: R. Graham Barr, Irving Associate Professor of Medicine and Associate Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01397721     History of Changes
Other Study ID Numbers: AAAD6395, R01HL093081-01
Study First Received: July 13, 2011
Last Updated: April 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Chronic Obstructive Pulmonary Disease (COPD)
pulmonary vasculature
pulmonary hypertension

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 02, 2015