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World Trade Center (WTC) CHEST

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01466218
First received: October 28, 2011
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition
Pulmonary Disease
Cardiac Disease
Cardiopulmonary Disease
Obstructive Sleep Apnea
Cardiovascular Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1012
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

World Trade Center rescue and recovery workers and volunteers who are enrolled in the World Trade Center Health Program-Clinical Center of Excellence, formerly known as the Medical Monitoring Treatment Program

Criteria

Inclusion Criteria:

  • World Trade Center responders who are currently enrolled in the World Trade Center Health Program-Clinical Center of Excellence, formerly known as the WTC Medical Monitoring and Treatment Program
  • Over the age of 39 years
  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: NCT01466218

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Mary Ann McLaughlin, MD, MPH Mount Sinai School of Medicine
  More Information

Additional Information:
Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01466218     History of Changes
Other Study ID Numbers: GCO 11-0618, BAA (2011-Q-13340)
Study First Received: October 28, 2011
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
pulmonary function abnormalities
pulmonary disease
cardiac disease
cardiopulmonary disease
obstructive sleep apnea
OSA
cardiovascular disease
CVD
particulate matter

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Pulmonary Heart Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014