N/A
N=46
Cleaner Air for Better Cardiac Biomarkers
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05379400 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) — -1.03; 2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Portable air cleaner (PAC) (Other); Sham Portable air cleaner (PAC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) |
-1.03; 2 | — |
| SECONDARY Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration |
2.698; 11.751 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT05379400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.