Cardiovascular DiseasesNCT05379400
Cleaner Air for Better Cardiac Biomarkers
A study testing Portable air cleaner (PAC) in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
This pilot project is a randomized, double-blind, sham-controlled trial investigating whether in-home air pollution reductions using portable air cleaners (PACs) can decrease circulating concentrations of biomarkers of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Portable air cleaner (PAC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥18 years old
- Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes)
- Participant is to understand/speak English or Spanish
- Participant can understand study procedures and give informed consent
- Participant has stable hypertension: no medication changes in prior 30 days, systolic BP <160 mm Hg and either ≥ 130 mm Hg without antihypertensive medications, or diagnosis of hypertension in medical records
- Able to measure home blood pressure twice daily
Show all 10Show fewer
- Able to participate in video conference for home equipment setup
- Able to visit clinic for blood draws before and after the study period
- Do not intend to sleep anywhere outside of primary bedroom for more than 48 consecutive hours or a total of 7 days during the study period.
- Ability to lift, or access to assistance with lifting, 20 lb to set up PAC in bedroom.
Who cannot join
- Participants who are unable to provide a minimum of at least one blood pressure measurement per day
- Participants with average home blood pressure monitor readings of a systolic blood pressure (SBP) >160 mmHg over any 10-day period during the study. This will be considered evidence of uncontrolled hypertension and will require study termination.
- Participants with known coronary artery disease
- Participants with known systemic inflammatory conditions (such as rheumatoid arthritis, inflammatory bowel disease, cancer)
- Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure Via Home Air Filtration
This pilot project is a randomized, double-blind, sham-controlled trial investigating whether in-home air pollution reductions using portable air cleaners (PACs) can decrease circulating concentrations of biomarkers of inflammation. Using both a targeted approach to study the established biomarker TNFa and an exploratory approach with a commercially available proteomic panel, the researchers will measure concentrations of biomarkers before and after four weeks of home PAC use in a cohort of 74 adults with hypertension recruited from NYU outpatient clinical settings. Participants will also track home blood pressure measurements for additional exploratory analysis of potential mediation of PAC-associated decreases in blood pressure by biomarker concentration changes.
Read the detailed description
In Aim 1, the researchers will evaluate associations with PAC use with a priori specified biomarker of inflammation, tumor necrosis factor alpha (TNFα). The researchers will determine if 4 weeks of home air filtration with PACs compared to sham is associated with significant reductions in TNFα concentrations when measured before and after intervention. Blood samples will be collected from 74 study participants before and after 4 weeks of PAC use (true and sham) for biomarker concentration measurement. In Aim 2, the researchers will determine if reductions in fine particulate matter (<2.5 μm in diameter, PM2.5) as a continuous variable are associated with significant reductions TNFα concentrations over a four-week period.
- Conditions
- Cardiovascular Diseases
- Being tested
- Portable air cleaner (PAC), Sham Portable air cleaner (PAC)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable air cleaner (PAC)Other
Commercially available Portable air cleaners (PAC) contain carbon filters that reduce volatile organic carbons and can reduce odors. Because of this, the researchers will remove the carbon filters from all air purifiers to preserve blinding. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.
Sham Portable air cleaner (PAC)Other
Sham Portable air cleaner (PAC) are commercially available portable air cleaners with the carbon filters and the HEPA filters removed. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.
| Study group | Role | What they receive |
|---|---|---|
| Portable Air Cleaner (PAC) group | Experimental | This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm. Receives: Other: Portable air cleaner (PAC) |
| Sham Portable Air Cleaner (PAC) group | Sham comparator | For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting. Receives: Other: Sham Portable air cleaner (PAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα)
Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.
Measured: Baseline, Week 4
Secondary outcomes (1)
Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration
Commercially available Particulate Matter (PM) monitors will record indoor PM2.5 concentrations using dual (backup) sensors, which store measurements on internal SD cards
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start11 Aug 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan D Newman, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379400
- Sponsor's protocol ID
- 22-00045
- Status last verified
- Oct 2024
- First submitted
- 12 May 2022
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure Via Home Air Filtration
- ClinicalTrials.gov ID
- NCT05379400
- Acronym / sponsor ID
- 22-00045
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project is a randomized, double-blind, sham-controlled trial investigating whether in-home air pollution reductions using portable air cleaners (PACs) can decrease circulating concentrations of biomarkers of inflammation. Using both a targeted approach to study the established biomarker TNFa and an exploratory approach with a commercially available proteomic panel, the researchers will measure concentrations of biomarkers before and after four weeks of home PAC use in a cohort of 74 adults with hypertension recruited from NYU outpatient clinical settings. Participants will also track home blood pressure measurements for additional exploratory analysis of potential mediation of PAC-associated decreases in blood pressure by biomarker concentration changes.
Detailed description
In Aim 1, the researchers will evaluate associations with PAC use with a priori specified biomarker of inflammation, tumor necrosis factor alpha (TNFα). The researchers will determine if 4 weeks of home air filtration with PACs compared to sham is associated with significant reductions in TNFα concentrations when measured before and after intervention. Blood samples will be collected from 74 study participants before and after 4 weeks of PAC use (true and sham) for biomarker concentration measurement. In Aim 2, the researchers will determine if reductions in fine particulate matter (<2.5 μm in diameter, PM2.5) as a continuous variable are associated with significant reductions TNFα concentrations over a four-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable Air Cleaner (PAC) group | Experimental | Other: Portable air cleaner (PAC)This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm. |
| Sham Portable Air Cleaner (PAC) group | Sham comparator | Other: Sham Portable air cleaner (PAC)For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is ≥18 years old
- Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes)
- Participant is to understand/speak English or Spanish
- Participant can understand study procedures and give informed consent
- Participant has stable hypertension: no medication changes in prior 30 days, systolic BP <160 mm Hg and either ≥ 130 mm Hg without antihypertensive medications, or diagnosis of hypertension in medical records
Key exclusion criteria (6 listed)
- Participants who are unable to provide a minimum of at least one blood pressure measurement per day
- Participants with average home blood pressure monitor readings of a systolic blood pressure (SBP) >160 mmHg over any 10-day period during the study. This will be considered evidence of uncontrolled hypertension and will require study termination.
- Participants with known coronary artery disease
- Participants with known systemic inflammatory conditions (such as rheumatoid arthritis, inflammatory bowel disease, cancer)
- Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable air cleaner (PAC)Commercially available Portable air cleaners (PAC) contain carbon filters that reduce volatile organic carbons and can reduce odors. Because of this, the researchers will remove the carbon filters from all air purifiers to preserve blinding. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team. | Other | Portable Air Cleaner (PAC) group |
| Sham Portable air cleaner (PAC)Sham Portable air cleaner (PAC) are commercially available portable air cleaners with the carbon filters and the HEPA filters removed. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team. | Other | Sham Portable Air Cleaner (PAC) group |
Primary outcome
Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα)
Time frame: Baseline, Week 4
Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.
1 secondary outcome
Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
Jonathan D Newman 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?
A study testing Portable air cleaner (PAC) in people with Cardiovascular Diseases, 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 10 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: finished, as of the sponsor's last update on 6 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) (time frame: Baseline, Week 4). 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 6 Dec 2024.