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

January 12, 2012 updated by: Columbia University

Endothelial Dysfunction, Biomarkers, and Lung Function (MESA LUNG)

The purpose of MESA-Lung is to assess the role of endothelial dysfunction and genetic susceptibility in subclinical COPD.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

4359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MESA cohort

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung Function
Time Frame: 2004-2011
2004-2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung Density
Time Frame: 2000-2011
2000-2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: R. Graham Barr, M.D., Dr.PH., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA7791
  • R01HL077612 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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