Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA (MESA-LUNG)
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2009 | ||||
| Last Updated Date | January 12, 2012 | ||||
| Start Date ICMJE | October 2004 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Lung Function [ Time Frame: 2004-2011 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00843271 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Lung Density [ Time Frame: 2000-2011 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | MESA cohort |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 4359 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years to 84 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00843271 | ||||
| Other Study ID Numbers ICMJE | AAAA7791, R01HL077612 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Columbia University | ||||
| Study Sponsor ICMJE | Columbia University | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | Columbia University | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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