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Search / Trial NCT05215171

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

Launched by NYU LANGONE HEALTH · Jan 18, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called CaRVD, is studying how exposure to dust and particles from the World Trade Center (WTC) on September 11, 2001, may affect heart and lung health. Researchers want to learn more about a condition known as WTC-cardiorespiratory and vascular dysfunction (WTC-CaRVD), which can lead to breathing problems and increased risk of heart disease. They will focus on understanding how these issues develop, especially in first responders from the Fire Department of New York (FDNY) who were exposed to the WTC dust.

To be eligible for this study, participants must be aged 21 to 90, have worked as FDNY rescue and recovery workers with documented exposure to the WTC site, and be part of a specific health program for WTC responders. Participants will undergo tests to assess their lung function and provide blood samples. The study aims to identify unique biomarkers in those affected by WTC-CaRVD, which may help in early diagnosis and treatment options. If you or someone you know meets these criteria and is interested, please consider joining this important research to better understand and address health issues related to WTC exposure.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Anna Nolan, MD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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