World Trade Center (WTC) CHEST

NCT ID: NCT01466218

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1012 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

FED

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Ann McLaughlin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

Herbert R, Moline J, Skloot G, Metzger K, Baron S, Luft B, Markowitz S, Udasin I, Harrison D, Stein D, Todd A, Enright P, Stellman JM, Landrigan PJ, Levin SM. The World Trade Center disaster and the health of workers: five-year assessment of a unique medical screening program. Environ Health Perspect. 2006 Dec;114(12):1853-8. doi: 10.1289/ehp.9592.

Reference Type: BACKGROUND

PMID: 17185275 (View on PubMed)

2010 Annual Report on 9/11 Health. Available at: www.nyc.gov/9-11HealthInfo.

Reference Type: BACKGROUND

Dominici F, Peng RD, Bell ML, Pham L, McDermott A, Zeger SL, Samet JM. Fine particulate air pollution and hospital admission for cardiovascular and respiratory diseases. JAMA. 2006 Mar 8;295(10):1127-34. doi: 10.1001/jama.295.10.1127.

Reference Type: BACKGROUND

PMID: 16522832 (View on PubMed)

Pope CA 3rd, Hansen ML, Long RW, Nielsen KR, Eatough NL, Wilson WE, Eatough DJ. Ambient particulate air pollution, heart rate variability, and blood markers of inflammation in a panel of elderly subjects. Environ Health Perspect. 2004 Mar;112(3):339-45. doi: 10.1289/ehp.6588.

Reference Type: BACKGROUND

PMID: 14998750 (View on PubMed)

Brook RD, Franklin B, Cascio W, Hong Y, Howard G, Lipsett M, Luepker R, Mittleman M, Samet J, Smith SC Jr, Tager I; Expert Panel on Population and Prevention Science of the American Heart Association. Air pollution and cardiovascular disease: a statement for healthcare professionals from the Expert Panel on Population and Prevention Science of the American Heart Association. Circulation. 2004 Jun 1;109(21):2655-71. doi: 10.1161/01.CIR.0000128587.30041.C8.

Reference Type: BACKGROUND

PMID: 15173049 (View on PubMed)

Hamade AK, Tankersley CG. Interstrain variation in cardiac and respiratory adaptation to repeated ozone and particulate matter exposures. Am J Physiol Regul Integr Comp Physiol. 2009 Apr;296(4):R1202-15. doi: 10.1152/ajpregu.90808.2008. Epub 2009 Jan 21.

Reference Type: BACKGROUND

PMID: 19158411 (View on PubMed)

Tankersley CG, Champion HC, Takimoto E, Gabrielson K, Bedja D, Misra V, El-Haddad H, Rabold R, Mitzner W. Exposure to inhaled particulate matter impairs cardiac function in senescent mice. Am J Physiol Regul Integr Comp Physiol. 2008 Jul;295(1):R252-63. doi: 10.1152/ajpregu.00697.2007. Epub 2008 Apr 30.

Reference Type: BACKGROUND

PMID: 18448608 (View on PubMed)

Croft L, McLaughlin MA, Bander J, et al. First Documentation of Cardiac Dysfunction Following Exposure to the World Trade Center Disaster. JACC. 2010;55:A86.E810.

Reference Type: BACKGROUND

Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.

Reference Type: BACKGROUND

PMID: 14532320 (View on PubMed)

Webber MP, Lee R, Soo J, Gustave J, Hall CB, Kelly K, Prezant D. Prevalence and incidence of high risk for obstructive sleep apnea in World Trade Center-exposed rescue/recovery workers. Sleep Breath. 2011 Sep;15(3):283-94. doi: 10.1007/s11325-010-0379-7. Epub 2010 Jul 1.

Reference Type: BACKGROUND

PMID: 20593281 (View on PubMed)

McLaughlin MA, Tamler R, Woodward M, Moline J, Sawit ST, O'Boyle J, Berookhim B, Lu K, Bar-Chama N. Hypogonadism is Independently Associated with Obstructive Sleep Apnea in Middle-aged Men. Poster session presented at: American Heart Association Quality of Care and Outcomes Research 2011 Scientific Sessions; 2011 May 12-14; Washington, DC.

Reference Type: BACKGROUND

Brook RD, Rajagopalan S, Pope CA 3rd, Brook JR, Bhatnagar A, Diez-Roux AV, Holguin F, Hong Y, Luepker RV, Mittleman MA, Peters A, Siscovick D, Smith SC Jr, Whitsel L, Kaufman JD; American Heart Association Council on Epidemiology and Prevention, Council on the Kidney in Cardiovascular Disease, and Council on Nutrition, Physical Activity and Metabolism. Particulate matter air pollution and cardiovascular disease: An update to the scientific statement from the American Heart Association. Circulation. 2010 Jun 1;121(21):2331-78. doi: 10.1161/CIR.0b013e3181dbece1. Epub 2010 May 10.

Reference Type: BACKGROUND

PMID: 20458016 (View on PubMed)

Clark RN, Green R, Swayze G, et al. Environmental studies of the World Trade Center area after the September 11, 2001 attack. Available at: http://pubs.usgs.gov/of/2001/ofr-01-0429.

Reference Type: BACKGROUND

Landrigan PJ, Lioy PJ, Thurston G, Berkowitz G, Chen LC, Chillrud SN, Gavett SH, Georgopoulos PG, Geyh AS, Levin S, Perera F, Rappaport SM, Small C; NIEHS World Trade Center Working Group. Health and environmental consequences of the world trade center disaster. Environ Health Perspect. 2004 May;112(6):731-9. doi: 10.1289/ehp.6702.

Reference Type: BACKGROUND

PMID: 15121517 (View on PubMed)

Lioy PJ, Weisel CP, Millette JR, Eisenreich S, Vallero D, Offenberg J, Buckley B, Turpin B, Zhong M, Cohen MD, Prophete C, Yang I, Stiles R, Chee G, Johnson W, Porcja R, Alimokhtari S, Hale RC, Weschler C, Chen LC. Characterization of the dust/smoke aerosol that settled east of the World Trade Center (WTC) in lower Manhattan after the collapse of the WTC 11 September 2001. Environ Health Perspect. 2002 Jul;110(7):703-14. doi: 10.1289/ehp.02110703.

Reference Type: BACKGROUND

PMID: 12117648 (View on PubMed)

McGee JK, Chen LC, Cohen MD, Chee GR, Prophete CM, Haykal-Coates N, Wasson SJ, Conner TL, Costa DL, Gavett SH. Chemical analysis of World Trade Center fine particulate matter for use in toxicologic assessment. Environ Health Perspect. 2003 Jun;111(7):972-80. doi: 10.1289/ehp.5930.

Reference Type: BACKGROUND

PMID: 12782501 (View on PubMed)

Other Identifiers

BAA (2011-Q-13340)

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 11-0618

Identifier Type: -

Identifier Source: org_study_id