Air Pollution, Atherosclerosis
Conditions
Keywords
Air pollution, Particulate matter, Air purifier, HEPA filter, Atherosclerosis, Ischemic Heart Disease, Thrombosis, Cardiovascular Disease
Brief summary
This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.
Detailed description
This double-blind, randomized, crossover trial will recruit 112 adults with ischemic heart disease history and will investigate potential benefits of indoor high efficiency particulate air (HEPA) filtration on ameliorating the progression of atherothrombosis. Participants will be contacted and recruited to the study based on inclusion and exclusion criteria. After consenting, participants will go through a total of 21-month study period comprised of true HEPA filtration and sham filtration, each of 9-month in duration, and a 3-month wash-out period. After 3-month wash-out period, participants will be switched to the other arm of the intervention. During the trial, project specialists will complete a series of home visits before, in the middle, and after each intervention session to set up air purifiers and indoor and outdoor air pollution monitors, as well as conduct interview to collect questionnaire data, measure vascular function, blood pressure, and collect biospecimens. Participants will self-monitor their daily blood pressure through out the intervention periods. In aim 1, researchers will assess the effect of a 9-month residential HEPA intervention on atherothrombosis progression in 112 participants. In aim 2, the researchers will examine the association between reduction in indoor PM2.5 exposure brought by the intervention and the changes in atherothrombosis progression indicators adjusting for outdoor PM2.5 exposure. In aim 3, researchers will examine atherothrombosis responses (both levels and slopes of change) to the HEPA intervention within four subgroups of participants: 1) non-Hispanics, 2) Hispanics, 3) females, and 4) males.
Interventions
DEVICEHEPA filtration
HEPA filters with the capacity to reduce PM2.5 levels
DEVICESham filtration
Sham filtration use the same appearance of air purifier but with HEPA filter removed.
Sponsors
University of Southern California
Duke University
National Institute of Environmental Health Sciences (NIEHS)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
A sham filter will be used in the control, to replace HEPA filter in the intervention group. Participants and investigators will be blinded to the intervention type, only investigators who will prepare air filters for intervention will be unblinded for the real air filter type.
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Age between 65 and 84 years old; * Weight ≥ 110 pounds; * Nonsmokers for at least 1 year; * Have ischemic heart disease history, clinically stable for 6 months, without any deterioration in symptoms or episodes of angina based on past electronic medical records; * Both English and Spanish speaking participants will be included in the recruitment; * Live in the Los Angeles County.
Exclusion criteria
* Have history of degenerative disease of the nervous system such as dementia and Alzheimer's; * Currently have active cancer treatments; * The residential house has already had HEPA filters; * Participants will move out from the current residential address in the next 2 years; * Participants will spend more than 1 month living outside the primary home; * Have any health conditions that prohibit collecting health and covariate data and biospecimens; * Participants' residential houses are not feasible for setting up air purifiers and air pollutants monitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Blood pressure will be monitored daily during each of the 9-month intervention | Differences between baseline and systolic and diastolic blood pressure measured during and after intervention |
| Change in carotid-femoral pulse wave velocity | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention |
| Change in augmentation index | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and augmentation index measured with Vicorder device during and after intervention |
| Change in von Willebrand factor | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and von Willebrand factor measured during and after intervention |
| Change in P-selectin | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and P-selectin measured during and after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and fasting glucose measured during and after intervention |
| Change in fasting insulin | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and fasting insulin measured during and after intervention |
| Changes in lipid profiles | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein, triglycerides, and total cholesterol levels measured during and after intervention |
| Change in C-reactive protein | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and C-reactive protein measured during and after intervention |
| Change in interleukin 6 | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and interleukin 6 measured during and after intervention |
| Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers | At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions | Differences between baseline and the relative abundance of 384 kinds of targeted cardiovascular disease-related proteomic markers, such as tumor necrosis factor, E-selectin, intercellular adhesion molecule 1, vascular cell adhesion molecule 1, and leptin, measured with Olink's Explore 384 cardiometabolic panel 1 during and after intervention. The Olink kit is a relative quantification assay and there are no units for the measurements. |
Countries
United States
Contacts
CONTACTZhanghua Chen, PhD
CONTACTJunfeng Zhang, PhD
PRINCIPAL_INVESTIGATORZhanghua Chen, PhD
University of Southern California
PRINCIPAL_INVESTIGATORJunfeng Zhang, PhD
Duke University
Outcome results
None listed