SAPIA: Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease History

Sponsor

University of Southern California (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05867381

Collaborator

Duke University (Other), National Institute of Environmental Health Sciences (NIEHS) (NIH)

112

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Air Pollution Atherosclerosis	Device: HEPA filtration Device: Sham filtration	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, 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.

Primary Purpose:

Prevention

Official Title:

Slowing Atherothrombosis Progression Through Indoor Air Filtration: A Crossover Trial in Hispanic and Non-Hispanic Adults With Ischemic Heart Disease History

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HEPA first and sham This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.	Device: HEPA filtration HEPA filters with the capacity to reduce PM2.5 levels Device: Sham filtration Sham filtration use the same appearance of air purifier but with HEPA filter removed.
Experimental: Sham first and HEPA This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.	Device: HEPA filtration HEPA filters with the capacity to reduce PM2.5 levels Device: Sham filtration Sham filtration use the same appearance of air purifier but with HEPA filter removed.

Arm

Intervention/Treatment

Experimental: HEPA first and sham

This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.

Device: HEPA filtration

HEPA filters with the capacity to reduce PM2.5 levels

Device: Sham filtration

Sham filtration use the same appearance of air purifier but with HEPA filter removed.

Experimental: Sham first and HEPA

This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.

Device: HEPA filtration

HEPA filters with the capacity to reduce PM2.5 levels

Device: Sham filtration

Sham filtration use the same appearance of air purifier but with HEPA filter removed.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 (a relative quantification assay) during and after intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.