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NCT Number: NCT05867381

Using Indoor Air Filtration to Slow Atherothrombosis Progression in 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.

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Key information

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Zhanghua Chen, PhD

CONTACT

[email protected]

323-442-2109

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEPA filtration

Device

HEPA filters with the capacity to reduce PM2.5 levels

Sham filtration

Device

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

Primary outcomes

  1. Change in blood pressure

    Time frame: 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

  2. Change in carotid-femoral pulse wave velocity

    Time frame: 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

  3. Change in augmentation index

    Time frame: 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

  4. Change in von Willebrand factor

    Time frame: 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

  5. Change in P-selectin

    Time frame: 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 outcomes

  1. Change in fasting glucose

    Time frame: 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

  2. Change in fasting insulin

    Time frame: 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

  3. Changes in lipid profiles

    Time frame: 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

  4. Change in C-reactive protein

    Time frame: 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

  5. Change in interleukin 6

    Time frame: 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

  6. Changes in 384 kinds of targeted cardiovascular disease-related proteomic markers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Junfeng Zhang, PhD

CONTACT

[email protected]

919-681-7782

Zhanghua Chen, PhD

CONTACT

[email protected]

323-442-2109

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Duke University
  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

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

Acronym: SAPIA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 22, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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