Actively Recruiting

Age: 21Years - 90Years
All Genders
NCT05215171

World Trade Center Particulate Matter Induced Cardiorespiratory and Vascular Dysfunction: a MultiOmic Approach (CaRVD)

Led by NYU Langone Health · Updated on 2026-02-04

100

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

World Trade Center Particulate Matter Induced Cardiorespiratory and Vascular Dysfunction: a MultiOmic Approach (CaRVD)

Who Can Participate

Age: 21Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21-90 years
  • FDNY rescue and recovery worker
  • Documented exposure to the World Trade Center site
  • Member enrolled in the World Trade Center Health Program
  • Able and willing to consent to study participation
  • Able and willing to undergo study procedures
  • Able to perform daily living activities independently
  • Currently light duty or retired FDNY firefighter
  • Spirometry test available within the last 24 months and post-9/11
  • Able to travel to and attend a single in-person visit at the study site
  • Pre-9/11 spirometry with FEV1% predicted above lower limit of normal or post-9/11 spirometry with FEV1 >80% predicted
  • No positive airway hyperreactivity testing before 9/11
  • Exposed at WTC site within two weeks after 9/11/2001
  • Entered World Trade Center Health Program before site closure on 7/24/2002
  • Serum sample available from first post-9/11 visit in biorepository
  • Not currently receiving treatment for cancer
  • Classified as having WTC airway hyperreactivity or designated control
Not Eligible

You will not qualify if you...

  • Unwilling to provide informed consent
  • Not enrolled in the World Trade Center Health Program
  • Do not meet eligibility or lack serum sample from first post-9/11 visit
  • Have active cancer, severe heart disease, significant cognitive impairment, eating disorders, serious psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant
  • Used high dose steroids (>20 mg prednisone or equivalent), hormonal treatments, chemotherapy, or testosterone supplementation in the past month
  • Life expectancy less than 6 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)

New York, New York, United States, 10016

Actively Recruiting

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Research Team

A

Anna Nolan, MD

CONTACT

A

Aida Fallah Zadeh

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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