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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Air Pollution
• Intervention / Treatment: Device: HEPA filtration; Device: Sham filtration

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhanghua Chen, PhD; Phone Number: 323-442-2109; Email: zhanghuc@usc.edu
• Study Contact Backup: Name: Junfeng Zhang, PhD; Phone Number: 919-681-7782; Email: junfeng.zhang@duke.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck School of Medicine, University of Southern California
      • Contact: Zhanghua Chen, PhD; Phone Number: 323-442-2109; Email: zhanghuc@usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Differences between baseline and systolic and diastolic blood pressure measured during and after intervention	Blood pressure will be monitored daily during each of the 9-month intervention
Change in carotid-femoral pulse wave velocity	Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in augmentation index	Differences between baseline and augmentation index measured with Vicorder device during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in P-selectin	Differences between baseline and P-selectin measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in von Willebrand factor	Differences between baseline and von Willebrand factor measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose	Differences between baseline and fasting glucose measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in fasting insulin	Differences between baseline and fasting insulin measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Changes in lipid profiles	Differences between baseline and low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein, triglycerides, and total cholesterol levels measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in C-reactive protein	Differences between baseline and C-reactive protein measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Change in interleukin 6	Differences between baseline and interleukin 6 measured during and after intervention	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions
Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers	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.	At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Duke University; National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Zhanghua Chen, PhD, University of Southern California; Principal Investigator: Junfeng Zhang, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Atherosclerosis; Ischemic Heart Disease; Thrombosis; Air pollution; Particulate matter; Air purifier; HEPA filter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: SAPIA_Study; R01ES033707 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No