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

Detailed Description:

Serious illness and injury following the September 11, 2001 (9/11) attacks on the World Trade Center (WTC) affects thousands of responders who worked on the WTC rescue and recovery effort. During this time, these individuals sustained exposure to a vast array of environmental toxins and physical hazards. The population of survivors presents a unique opportunity to rigorously examine the effects of inhaled particulate matter on risk of persistent pulmonary and chronic cardiopulmonary disease.

Original reports of 9,500 WTC responders examined between July 2002 and April 2004, noted abnormal pulmonary function results in one-third of participants. Further studies of this population have demonstrated persistent changes in pulmonary function tests 9 years after exposure (2010 Annual Report on 9/11 Health). Numerous complex interactions between pulmonary and cardiovascular systems exist. In fact, at the molecular level, evidence supports an integral role for reactive oxygen species (ROS)-dependent pathways in the instigation of pulmonary oxidative stress, systemic pro-inflammatory responses, vascular dysfunction and atherosclerosis.

Studies in animals have shown that inhalation of particles can lead to weakening of the heart muscle. In addition, patients who have developed pulmonary disease from inhalation of particulate matter may develop increased pressures in the pulmonary arteries, as well as dysfunction of the right ventricle of the heart. Finally, patients who have suffered blockage of the coronary arteries may exhibit abnormalities in the heart function that may be detected by an echocardiogram.

Preliminary work by our group revealed echocardiographic evidence of cardiac abnormalities in a subset of 1190 WTC responders. Diastolic dysfunction, or impaired ventricular relaxation, is known to accompany aging and is associated with hypertensive heart disease. In our analysis of subjects < 50 years of age, BMI < 30, and lacking a diagnosis of hypertension, the investigators found a prevalence of diastolic dysfunction of 47%. Importantly, when the population was narrowed to exclude former or current smokers, and those with LV abnormalities, 12% had abnormalities of RV diastolic function. The investigators propose to analyze the relationship between pulmonary function abnormalities and evidence of diastolic dysfunction.

Persuasive data implicates obstructive sleep apnea (OSA) in the development of hypertension, arrhythmias, vascular dysfunction and cardiac disease. Webber et al demonstrated an increased prevalence of obstructive sleep apnea (OSA) among firefighters exposed to the WTC disaster, and our group has demonstrated a similar prevalence of screen positive for OSA among 2500 law enforcement officers present at Ground Zero. The relationship between OSA and risk of cardiac disease involves similar pathophysiologic pathways including inflammation and impaired vascular reactivity.

In addition to the traditional risk factors for cardiovascular disease (CVD), studies have indicated that exposure to inhalation of particulate matter (PM) contribute to CV morbidity and mortality. The 2010 American Heart Association Scientific Statement on Particulate Matter Air Pollution and Cardiovascular Disease provided compelling evidence of increased risk due to air pollution. Although the exact mechanisms by which PM cause these toxic effects are not adequately understood, and it is likely that different mechanisms are responsible for acute and chronic effects. In addition, PM consists of many different components, and different components may affect CVD by different mechanisms, such as electrophysiologic changes, inflammation, coagulation, endothelial cell function effects and atherosclerosis. In summary, thousands of WTC responders sustained exposure to thousands of tons of coarse and fine PM, cement dust, glass fibers, asbestos, lead, hydrochloric acid, polychlorinated biphenyls, organochlorine pesticides, and polychlorinated dioxins and furans. It is unknown to what extent the exposure to PM modified risk of developing atherosclerotic disease, in addition to the pulmonary effects and effects on cardiac function.

  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:
Apnea
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Pulmonary Heart Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014