Clinical trial NCT05867381: Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History
Official title: Slowing Atherothrombosis Progression Through Indoor Air Filtration: A Crossover Trial in Hispanic and Non-Hispanic Adults With Ischemic Heart Disease History
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Air Pollution
Atherosclerosis
Keywords: Air pollution
Particulate matter
Air purifier
HEPA filter
Atherosclerosis
Ischemic Heart Disease
Thrombosis
Cardiovascular Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2023-05-22
Enrollment: 112
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood pressure
timeFrame: Blood pressure will be monitored daily during each of the 9-month intervention
measure: Change in carotid-femoral pulse wave velocity
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in augmentation index
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in von Willebrand factor
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in P-selectin
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Secondary outcomes:
measure: Change in fasting glucose
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in fasting insulin
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Changes in lipid profiles
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in C-reactive protein
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Change in interleukin 6
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
measure: Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers
timeFrame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Zhanghua Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Junfeng Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: