ClinicalTrials.gg
RecruitingNCT05867381SAPIAUpdated Jun 8, 2026

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

An interventional study of HEPA filtration and Sham filtration in Air Pollution and Atherosclerosis, sponsored by University of Southern California. Recruiting at 1 site in United States. Open to participants aged 65 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by University of Southern California · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
65 Years to 84 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 468 studies in Atherosclerosis with a site in United States — 47 open to participants now, 75 under way, 17 of them phase 3. Atherosclerosis · United States.

Planned enrollment
167th of 328
112 · median 119
Started
2023
with 11 others
No phase
103 of 468
21 open now
Primary completion
2028-06
later than 51 of 70 live
Registered
415th of 468
by date

Among the 468 studies in Atherosclerosis with a site in United States, this one is the 167th largest by planned enrollment of the 328 interventional ones that give a count, is one of 12 that started in 2023, is one of 103 with no phase, reaches primary completion later than 51 of the 70 other live ones, and was the 415th registered.

Atherosclerosis

1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.

Browse Atherosclerosis studies →

Open to participants now

47 of the 468 studies in Atherosclerosis with a site in United States are open now. Recruiting first, the newest first:

42 more — sign in →

All 47 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 161 Atherosclerosis studies recruiting now, 84 (52%) set no upper age limit and 33 (20%) stop at 75 or younger; 16 take children under 18; 33 take healthy volunteers.

This study: 65 Years to 84 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Air Pollution
  • Atherosclerosis

Keywords

  • Air pollution
  • Particulate matter
  • Air purifier
  • HEPA filter
  • Atherosclerosis
  • Ischemic Heart Disease
  • Thrombosis
  • Cardiovascular Disease
04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
112 participants (estimated)

Study arms

  • 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 · Device: Sham filtration

  • 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 · Device: Sham filtration

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.

06

What researchers measure

Primary outcomes

  1. Change in blood pressure

    Differences between baseline and systolic and diastolic blood pressure measured during and after intervention

    Time frame: Blood pressure will be monitored daily during each of the 9-month intervention

  2. Change in carotid-femoral pulse wave velocity

    Differences between baseline and carotid-femoral pulse wave velocity measured with Vicorder device during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  3. Change in augmentation index

    Differences between baseline and augmentation index measured with Vicorder device during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  4. Change in von Willebrand factor

    Differences between baseline and von Willebrand factor measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  5. Change in P-selectin

    Differences between baseline and P-selectin measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

Secondary outcomes

  1. Change in fasting glucose

    Differences between baseline and fasting glucose measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  2. Change in fasting insulin

    Differences between baseline and fasting insulin measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  3. 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

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  4. Change in C-reactive protein

    Differences between baseline and C-reactive protein measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  5. Change in interleukin 6

    Differences between baseline and interleukin 6 measured during and after intervention

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

  6. 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.

    Time frame: At the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Jun 2028, 59 months after the start.

Of 178 non-industry interventional studies with no phase under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 59 months is above that.

Counting every sponsor, half of 198 studies reached it within 30 months; a quarter within 17 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2023
First posted
May 22, 2023
StartActual
Jul 11, 2023
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05867381
Responsible party
Zhanghua Chen (Assistant Professor, University of Southern California) — Principal investigator
First posted
May 22, 2023
Start date
Jul 11, 2023
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jun 8, 2026

Study contacts

Zhanghua Chen, PhD
Contact
zhanghuc@usc.edu
323-442-2109
Junfeng Zhang, PhD
Contact
junfeng.zhang@duke.edu
919-681-7782
Zhanghua Chen, PhD
principal investigator · University of Southern California
Junfeng Zhang, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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