Cardiorespiratory and Vascular DysfunctionNCT05215171
World Trade Center Particulate Matter Induced Cardiorespiratory and Vascular Dysfunction: a MultiOmic Approach (CaRVD)
An observational study of Cardiorespiratory and Vascular Dysfunction and Obstructive Airway Disease, run by NYU Langone Health at 1 site in United States.
Trial 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 intense deposition of particulate matter (WTC-PM) into aerodigestive system. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Cardiorespiratory and Vascular Dysfunction, Obstructive Airway Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both Male and female subjects 21-90 year old will be enrolled. FDNY WTC exposed 1st responders enrolled in the WTC-Health Program.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aida Fallah Zadeh contact
United States1 site, 1 recruiting
- Recruiting
NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York, New York, 10016
Anna Nolan, MD
About this study
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.
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| World Trade Center - Airway Hyperreactivity (WTC-AHR) | 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. | |
| Control Group | Cohort Controls will be randomly selected 10% of the baseline cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Heme Oxygenase-1 (HO-1)
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of Glutathione
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of Total Antioxidant Capacity (TAC)
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of Superoxide Dismutase (SOD)
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of Macrophage inflammatory protein-2 (MIP-2)
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of C-reactive protein (CRP)
All serum will be thawed once and assayed for biomarkers
Measured: up to Day 365
Levels of fractional exhaled nitric oxide (FeNO)
FeNO will be quantified using NIOX VERO®
Measured: 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.
Measured: up to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start30 Mar 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory and Vascular DysfunctionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Anna Nolan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215171
- Sponsor's protocol ID
- 21-00682
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- World Trade Center Particulate Matter Induced Cardiorespiratory and Vascular Dysfunction: a MultiOmic Approach (CaRVD)
- ClinicalTrials.gov ID
- NCT05215171
- Acronym / sponsor ID
- 21-00682
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| World Trade Center - Airway Hyperreactivity (WTC-AHR) | – | –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. |
| Control Group | – | –Cohort Controls will be randomly selected 10% of the baseline cohort |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both Male and female subjects 21-90 year old will be enrolled. FDNY WTC exposed 1st responders enrolled in the WTC-Health Program.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of Heme Oxygenase-1 (HO-1)
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of Glutathione
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of Total Antioxidant Capacity (TAC)
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of Superoxide Dismutase (SOD)
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of Macrophage inflammatory protein-2 (MIP-2)
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of C-reactive protein (CRP)
Time frame: up to Day 365
All serum will be thawed once and assayed for biomarkers
Levels of fractional exhaled nitric oxide (FeNO)
Time frame: up to Day 365
FeNO will be quantified using NIOX VERO®
Score on St. George's Respiratory Questionnaire (SGRQ-C)
Time frame: up to Day 365
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aida Fallah Zadeh contact
Anna Nolan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiorespiratory and Vascular Dysfunction and Obstructive Airway Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Nolan, MD (646-501-6783, Anna.nolan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Heme Oxygenase-1 (HO-1) (time frame: up to Day 365). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.