NCT01466218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,012

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

2.6 years

First QC Date

October 28, 2011

Last Update Submit

June 27, 2014

Conditions

Pulmonary DiseaseCardiac DiseaseCardiopulmonary DiseaseObstructive Sleep ApneaCardiovascular Disease

Keywords

pulmonary function abnormalitiespulmonary diseasecardiac diseasecardiopulmonary diseaseobstructive sleep apneaOSAcardiovascular diseaseCVDparticulate matter

Outcome Measures

Primary Outcomes (1)

  • Spirometry

    To evaluate the persistent longitudinal effects of pulmonary function abnormalities (spirometry) and additionally demonstrate prevalence of impaired DLCO in WTC responders.

    day 1

Secondary Outcomes (4)

  • RV diastolic dysfunction

    day 1

  • LV diastolic function

    day 1

  • obstructive sleep apnea risk

    day 1

  • microvascular and cardiovascular disease

    day 1

Study Arms (1)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (16)

  • 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.

    PMID: 17185275BACKGROUND

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

    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.

    PMID: 16522832BACKGROUND

  • 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.

    PMID: 14998750BACKGROUND

  • 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.

    PMID: 15173049BACKGROUND

  • 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.

    PMID: 19158411BACKGROUND

  • 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.

    PMID: 18448608BACKGROUND

  • 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.

    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.

    PMID: 14532320BACKGROUND

  • 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.

    PMID: 20593281BACKGROUND

  • 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.

    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.

    PMID: 20458016BACKGROUND

  • 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.

    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.

    PMID: 15121517BACKGROUND

  • 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.

    PMID: 12117648BACKGROUND

  • 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.

    PMID: 12782501BACKGROUND

MeSH Terms

Conditions

Lung DiseasesHeart DiseasesPulmonary Heart DiseaseSleep Apnea, ObstructiveCardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Mary Ann McLaughlin, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 7, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

US(1)