An observational study in Cardiorespiratory and Vascular Dysfunction and Obstructive Airway Disease, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by NYU Langone Health · Observational
Particulate matter (PM) associated cardiorespiratory and vascular dysfunction (CaRVD) poses a significant global health burden. The World Trade Center (WTC) destruction on September 11, 2001 led to an intense deposition of particulate matter (WTC-PM) into aerodigestive system. WTC associated morbidities include respiratory, gastrointestinal, chronic rhinosinusitis, cancer, mental health concerns and more recently a focus has been on cardiovascular disease. This proposal will investigate the development of WTC-cardiorespiratory and vascular dysfunction (WTC-CaRVD) which is firmly within the purview of the James Zadroga 9/11 Health and Compensation Act.
WTC-PM exposure causes heterogeneous obstructive airways disease (OAD) patterns, which include airway hyperreactivity (AHR) and loss of FEV1. Early diagnosis and therapeutic options are few, in part due to limited understanding of their pathogenesis. While pulmonary vascular changes are classically thought to occur due to the hypoxemia of late OAD, recent investigations show that vascular dysfunction occurs early in OAD. This vascular hypothesis of OAD postulates that pulmonary vasculature remodeling leads to loss of lung function. Early evidence of WTC-CaRVD includes increased prevalence of cardiovascular disease risk factors such as metabolic syndrome, elevated pulmonary artery/aorta ratio, and cardiovascular biomarkers (such as CRP). Murine models of WTC-PM exposure show inflammation, AHR both acutely and persistently and reflect what is seen in FDNY 1st responders. Airway and cardiac remodeling were also persistent features of WTC-PM exposure in the study team's murine models. Therefore, the study team will focus on Heme Oxygenase-1 (HO-1), a mediator of oxidative stress, known to stimulate collagen formation and is also induced after WTC-PM exposure. Furthermore, pathways and mechanisms of WTC-CaRVD warrant further study and are the focus of the 5-year proposal.
The HYPOTHESIS is that WTC-PM exposure causes WTC-CaRVD mediated by HO-1. First responders with AHR will have features of WTC-CaRVD, and will demonstrate a unique biomarker profile compared to controls.
202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.
This study's planned enrollment of 100 is below the median of 185 across 48 observational studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Both Male and female subjects 21-90 year old will be enrolled. FDNY WTC exposed 1st responders enrolled in the WTC-Health Program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
WTC-AHR cases are defined as having either a positive MCT (PC20\<16) and/or positive BDR (by ATS/ERS guidelines with improvement of FEV1 by 12% and at least 200mL) post-9/11.
Cohort Controls will be randomly selected 10% of the baseline cohort
Levels of Heme Oxygenase-1 (HO-1)
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of Glutathione
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of Total Antioxidant Capacity (TAC)
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of Superoxide Dismutase (SOD)
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of Macrophage inflammatory protein-2 (MIP-2)
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of C-reactive protein (CRP)
All serum will be thawed once and assayed for biomarkers
Time frame: up to Day 365
Levels of fractional exhaled nitric oxide (FeNO)
FeNO will be quantified using NIOX VERO®
Time frame: up to Day 365
Score on St. George's Respiratory Questionnaire (SGRQ-C)
SGRQ-C is designed to assess how one's breathing is troubling a participant and how it affects one's life. The questionnaire consists of 14 questions. The total score range is 0-54; the higher the score, the worse the chest trouble.
Time frame: up to Day 365
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data and researchers who provide a methodologically sound proposal will have access to the data upon reasonable request. Requests should be directed to anna.nolan@med.nyu.edu. To gain access, data requestors will need to sign a data access agreement.
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Jun 2026, 39 months after the start.
Of 25 observational studies under Lung Diseases, Obstructive, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 53. This study's planned 39 months is above that.
How these figures are worked out, and which studies are left out of them.
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