Investigating health effects of World Trade Center dust on firefighters

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

This study looks at how breathing in dust from the World Trade Center affects the heart and lungs of firefighters who were there during the rescue efforts.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 21 Years to 90 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (New York, New York)
• Trial ID: NCT05215171 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the health impacts of particulate matter from the World Trade Center destruction on firefighters who were exposed during rescue and recovery efforts. It aims to understand the development of cardiorespiratory and vascular dysfunction associated with this exposure, particularly in relation to obstructive airway disease. The study will involve assessing participants' health through spirometry and other evaluations to gather data on their respiratory and cardiovascular conditions. The findings could help in identifying early diagnostic markers and therapeutic options for affected individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are FDNY rescue and recovery workers aged 21-90 who have documented exposure to the World Trade Center site.

Not a fit: Patients who were not exposed to the World Trade Center site or do not have documented health issues related to that exposure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of cardiorespiratory and vascular issues in firefighters exposed to WTC dust.

How similar studies have performed: Other studies have shown significant health impacts related to particulate matter exposure, suggesting that this approach could yield valuable insights.

Eligibility criteria

Inclusion Criteria:

1. Age 21-90
2. FDNY rescue and recovery worker
3. Documented WTC exposure
4. Consented/Enrolled member of the WTC-HP
5. Subjects are willing and able to consent for themselves to study enrollment
6. Subjects are willing and able to participate in study procedures
7. Are able to perform their activities of daily living independently
8. Are either light duty or retired FDNY Firefighters
9. Spirometry available within the last 24 months, and at a post-9/11 visit.
10. Have means to accommodate transportation to/from in-person visit Are able to attend a single visit at the CTSI (462 1st Avenue, C \& D 4th Floor)
11. Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 \>80% predicted.
12. No recorded positive AHR testing prior to 9/11
13. Exposure at the WTC-site within 2 weeks of 9/11/2001
14. Entered WTC-HP before the site closure on 7/24/2002
15. Serum from their first post 9/11 WTC-HP visit is available in the biorepository and may be assayed
16. Are not currently being treated for malignancy
17. Subjects will either need to be defined as having WTC-AHR or be designated controls

Exclusion Criteria:

1. Unwilling to complete an informed consent.
2. Not enrolled in the WTC-HP
3. Do not meet eligibility criteria or did not have serum available in the biorepository from the first post 9/11 WTC-HP visit.
4. Have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
5. High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
6. Life-expectancy \< 6 months

Where this trial is running

New York, New York

• NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC) — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Anna Nolan, MD — NYU Langone Health
• Study coordinator: Anna Nolan, MD

Conditions: Cardiorespiratory and Vascular Dysfunction, Obstructive Airway Disease