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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01397721
First received: July 13, 2011
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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:
  • Measure of Endothelial microparticles (EMPs) [ Time Frame: Up to 2 years from the start of study ] [ Designated as safety issue: No ]

    Circulating EMPs and cells are abnormal in severe, moderate and mild COPD compared to controls. In cases:

    1. Numbers of CD31+/CD42 EMPs reflective of apoptosis are elevated;
    2. Numbers of circulating endothelial cells (CEC), resulting from endothelial injury, are elevated;
    3. Numbers of EPCs, involved in endothelial repair, are decreased


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.


Estimated Enrollment: 325
Study Start Date: May 2009
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) is the fourth 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 cross-sectional study of smokers nested among the MESA-Lung (AAAA7791) and 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 cross-sectional study of smokers nested within the MESA-Lung and EMCAP cohorts of 325 participants (125 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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 125 participants will be recruited from EMCAP at Columbia, and approximately 200 participants will be recruited from MESA (50 at Columbia; 50 at John Hopkins University; 50 at North Western University; and 50 at University of California University).

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 [COPD cases do not have a restrictive ventilatory defect by definition]).

Criteria

Inclusion Criteria:

  • age 50-75 years at time of enrollment
  • ever smokers (10 or more packyears)
  • 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 ([eGFR] < 60 mL/min/1.73 m2),
  • cancer,
  • atrial fibrillation, and
  • contraindications to magnetic resonance imagine (MRI), gadolinium, albuterol or spirometry testing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397721

Contacts
Contact: R. Graham Barr, MD, DrPh 212 305 4895 rgb9@columbia.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Olga Castro-Diehl    212-305-9462    oc83@columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: R. Graham Barr, M.D., Dr.PH. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01397721     History of Changes
Other Study ID Numbers: AAAD6395
Study First Received: July 13, 2011
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 23, 2014