World Trade Center (WTC) CHEST

June 27, 2014 updated by: Icahn School of Medicine at Mount Sinai

Pulmonary Abnormalities, Diastolic Dysfunction, and World Trade Center Exposure: Implications for Diagnosis and Treatment

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1012

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: day 1
To evaluate the persistent longitudinal effects of pulmonary function abnormalities (spirometry) and additionally demonstrate prevalence of impaired DLCO in WTC responders.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RV diastolic dysfunction
Time Frame: day 1
To determine the relationship between pulmonary function abnormalities (spirometry and DLCO) and cardiac dysfunction using echocardiograms to measure right ventricular (RV) diastolic dysfunction.
day 1
LV diastolic function
Time Frame: day 1
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.
day 1
obstructive sleep apnea risk
Time Frame: day 1
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.
day 1
microvascular and cardiovascular disease
Time Frame: day 1
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.
day 1

Collaborators and Investigators

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

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute for Occupational Safety and Health (NIOSH/CDC)

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

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

November 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-0618
  • BAA (2011-Q-13340) (Other Identifier: NIOSH)

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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