Pulmonary DiseaseNCT01466218
World Trade Center (WTC) CHEST
An observational study of Pulmonary Disease and Cardiac Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Cardiac Disease, Cardiopulmonary Disease
- How many people
- 1,012 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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
- Keywords
- pulmonary function abnormalities, pulmonary disease, cardiac disease, cardiopulmonary disease, obstructive sleep apnea, OSA, cardiovascular disease, CVD, particulate matter
- Medical subject headings
- Lung Diseases, Heart Diseases, Pulmonary Heart Disease, Sleep Apnea, Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
To evaluate the persistent longitudinal effects of pulmonary function abnormalities (spirometry) and additionally demonstrate prevalence of impaired DLCO in WTC responders.
Measured: day 1
Secondary outcomes (4)
RV diastolic dysfunction
To determine the relationship between pulmonary function abnormalities (spirometry and DLCO) and cardiac dysfunction using echocardiograms to measure right ventricular (RV) diastolic dysfunction.
Measured: day 1
LV diastolic function
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.
Measured: day 1
obstructive sleep apnea risk
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.
Measured: day 1
microvascular and cardiovascular disease
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Mary Ann McLaughlin, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466218
- Sponsor's protocol ID
- GCO 11-0618
- Other IDs
- BAA (2011-Q-13340)
- Status last verified
- Jun 2014
- First submitted
- 28 Oct 2011
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 171852752010 Annual Report on 9/11 Health. Available at: www.nyc.gov/9-11HealthInfo.
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.
PubMed 16522832Pope 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.
PubMed 14998750Brook 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.
PubMed 15173049Hamade 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.
PubMed 19158411Tankersley 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.
PubMed 18448608Croft 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.
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.
PubMed 14532320Webber 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.
PubMed 20593281McLaughlin 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.
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.
PubMed 20458016Clark 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.
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.
PubMed 15121517Lioy 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.
PubMed 12117648
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Abnormalities, Diastolic Dysfunction, and World Trade Center Exposure: Implications for Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT01466218
- Acronym / sponsor ID
- GCO 11-0618
- Conditions
- Pulmonary Disease, Cardiac Disease, Cardiopulmonary Disease, Obstructive Sleep Apnea, Cardiovascular Disease
- Keywords
- pulmonary function abnormalities, pulmonary disease, cardiac disease, cardiopulmonary disease, obstructive sleep apnea, OSA, cardiovascular disease, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
RV diastolic dysfunction
Time frame: day 1
LV diastolic function
Time frame: day 1
obstructive sleep apnea risk
Time frame: day 1
microvascular and cardiovascular disease
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 17185275Herbert 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.
- Background2010 Annual Report on 9/11 Health. Available at: www.nyc.gov/9-11HealthInfo.
- Background: PubMed 16522832Dominici 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.
- Background: PubMed 14998750Pope 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.
- Background: PubMed 15173049Brook 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.
- Background: PubMed 19158411Hamade 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.
- Background: PubMed 18448608Tankersley 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.
- BackgroundCroft 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: PubMed 14532320Shamsuzzaman 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.
- Background: PubMed 20593281Webber 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.
- BackgroundMcLaughlin 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: PubMed 20458016Brook 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ann McLaughlin, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Cardiac Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01466218, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.