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Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA (MESA-LUNG)

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ClinicalTrials.gov Identifier: NCT00843271
Recruitment Status : Unknown
Verified January 2012 by Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2009
Last Update Posted : January 16, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date February 12, 2009
First Posted Date February 13, 2009
Last Update Posted Date January 16, 2012
Study Start Date October 2004
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2009)
Lung Function [ Time Frame: 2004-2011 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2009)
Lung Density [ Time Frame: 2000-2011 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA
Official Title Endothelial Dysfunction, Biomarkers, and Lung Function (MESA LUNG)
Brief Summary The purpose of MESA-Lung is to assess the role of endothelial dysfunction and genetic susceptibility in subclinical COPD.
Detailed Description

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States, and morbidity and mortality from COPD continue to rise. Despite the magnitude of the problem, therapeutic options are limited - particularly in comparison to cardiovascular disease. Smoking cessation is essential to the treatment and prevention of COPD. However, although smoking is the principal cause of COPD, only a minority of smokers develops symptomatic COPD and many former smokers develop COPD years to decades after they have stopped smoking. The only other medical intervention proven to reduce mortality from COPD is supplemental oxygen therapy. There is therefore an urgent need for newer understandings of the pathophysiology of COPD that might lead to the development of better therapies for COPD.

MESA-Lung is ancillary of the ongoing Multi-Ethnic Study of Atherosclerosis (MESA). MESA-lung will utilize the various existing measures of endothelial function that have been already been collected in MESA (flow-mediated dilatation [FMD] and related biomarkers and gene polymorphisms) to test the hypotheses that the endothelial dysfunction occurs in the clinical COPD.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population MESA cohort
Condition
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Emphysema
  • Endothelial Dysfunction
Intervention Not Provided
Study Groups/Cohorts MESA Lung
MESA-Lung is an ancillary study of the Multi-Ethnic Study of Atherosclerosis (MESA). MESA, established in 1999, is well characterized, multi-ethnic (white, Black, Hispanic and Chinese), and multi-center (Columbia, Johns Hopkins, Northwestern, UCLA, Minnesota,and Wake Forest) prospective cohort study. MESA-Lung included a 60% random sample of the MESA cohort at the six Field Centers in Exam 3 and Exam 4, stratified on race/ethnicity.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: February 12, 2009)
4359
Original Actual Enrollment Same as current
Estimated Study Completion Date November 2012
Estimated Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A random sample of MESA participants active at Exam 3 and/or 4.

Exclusion Criteria:

  • MESA participants without MESA Exam 3 or 4 measurements.
  • MESA participants without FMD measurements in Exam 1.
  • MESA participants who have not consented to genetic testing.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00843271
Other Study ID Numbers AAAA7791
R01HL077612 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Columbia University
Study Sponsor Columbia University
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: R. Graham Barr, M.D., Dr.PH. Columbia University
PRS Account Columbia University
Verification Date January 2012