Status:
RECRUITING
World Trade Center Particulate Matter Induced Cardiorespiratory and Vascular Dysfunction: a MultiOmic Approach (CaRVD)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Conditions:
Cardiorespiratory and Vascular Dysfunction
Obstructive Airway Disease
Eligibility:
All Genders
21-90 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age 21-90
- FDNY rescue and recovery worker
- Documented WTC exposure
- Consented/Enrolled member of the WTC-HP
- Subjects are willing and able to consent for themselves to study enrollment
- Subjects are willing and able to participate in study procedures
- Are able to perform their activities of daily living independently
- Are either light duty or retired FDNY Firefighters
- Spirometry available within the last 24 months, and at a post-9/11 visit.
- 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)
- Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 \>80% predicted.
- No recorded positive AHR testing prior to 9/11
- Exposure at the WTC-site within 2 weeks of 9/11/2001
- Entered WTC-HP before the site closure on 7/24/2002
- Serum from their first post 9/11 WTC-HP visit is available in the biorepository and may be assayed
- Are not currently being treated for malignancy
- Subjects will either need to be defined as having WTC-AHR or be designated controls
Exclusion
- Unwilling to complete an informed consent.
- Not enrolled in the WTC-HP
- Do not meet eligibility criteria or did not have serum available in the biorepository from the first post 9/11 WTC-HP visit.
- 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.
- High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
- Life-expectancy \< 6 months
Key Trial Info
Start Date :
March 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05215171
Start Date
March 30 2023
End Date
June 1 2027
Last Update
March 12 2025
Active Locations (1)
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1
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, United States, 10016