World Trade Center (WTC) CHEST
This project will evaluate the effects of World Trade Center (WTC) exposure in WTC responders 10-13 years following the events of 9/11. Prior studies have described persistent pulmonary function abnormalities in a significant portion of responders. The investigators study seeks to examine the relationship between pulmonary function abnormalities and other markers of chronic cardiopulmonary disease and further elucidate the pathophysiologic effects of exposure to inhaled particulate matter (PM) on 9/11. This study will provide critical information regarding risk of exposure to PM, risk factors for disease and potential for improvements in diagnosis and treatment.
Obstructive Sleep Apnea
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Pulmonary Abnormalities, Diastolic Dysfunction, and World Trade Center Exposure: Implications for Diagnosis and Treatment|
- Spirometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]To evaluate the persistent longitudinal effects of pulmonary function abnormalities (spirometry) and additionally demonstrate prevalence of impaired DLCO in WTC responders.
- RV diastolic dysfunction [ Time Frame: day 1 ] [ Designated as safety issue: No ]To determine the relationship between pulmonary function abnormalities (spirometry and DLCO) and cardiac dysfunction using echocardiograms to measure right ventricular (RV) diastolic dysfunction.
- LV diastolic function [ Time Frame: day 1 ] [ Designated as safety issue: No ]To evaluate the association between levels of exposure to inhaled particulate matter on cardiac dysfunction as measured by left ventricular (LV) diastolic function or evidence of subclinical atherosclerosis with high risk coronary calcium scores in WTC responders.
- obstructive sleep apnea risk [ Time Frame: day 1 ] [ Designated as safety issue: No ]To determine the risks of developing obstructive sleep apnea (OSA) in the WTC responder population, and to evaluate the effect of OSA on mediating diastolic dysfunction.
- microvascular and cardiovascular disease [ Time Frame: day 1 ] [ Designated as safety issue: No ]To demonstrate specific mediators and pathways that link effects of inhaled particulate matter to microvascular and cardiovascular disease. This objective will be explored using measurements of vascular reactivity (peripheral arterial tonometry) and serum inflammatory and hemostatic markers from blood stored at the initial monitoring visit, as well as current blood samples.
|Study Start Date:||November 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
WTC Volunteers and Workers
Any current participant of the World Trade Center Health Program-Clinical Center of Excellence, formerly known as World Trade Center Medical Monitoring and Treatment Program
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01466218
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Mary Ann McLaughlin, MD, MPH||Mount Sinai School of Medicine|