What side effects are associated with this type of intervention?

Indoor air filtration systems, used to reduce PM2.5 exposure, are generally safe with minimal side effects. Potential issues include noise disturbance, the need for regular maintenance and filter replacement, and the risk of mold or bacterial growth if not properly maintained.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the direct treatment of air pollution exposure. However, interventions like indoor air filtration systems are being studied for their potential to reduce PM2.5 exposure and slow the progression of atherothrombosis in individuals with ischemic heart disease. While the FDA has approved various medications for managing cardiovascular conditions exacerbated by air pollution, such as statins and antihypertensives, the focus on air filtration as a preventive measure is a novel approach currently under investigation.

What other types of research exist?

Promising novel alternatives to indoor air filtration for reducing PM2.5 exposure and slowing atherothrombosis progression include: 1) Use of portable air purifiers with HEPA filters, which can be more effective in specific areas of the home. 2) Implementation of green infrastructure, such as urban green spaces and green roofs, which can reduce ambient air pollution levels. 3) Personal protective equipment like N95 masks, which can significantly reduce inhalation of fine particulate matter. 4) Anti-inflammatory and antioxidant medications that target the systemic effects of air pollution exposure. 5) Community-level interventions, such as traffic management and industrial emission controls, to reduce overall air pollution levels.

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Air Filtration

Air Filtration for Heart Disease (SAPIA Trial)

N/A

Recruiting

Led By Zhanghua Chen, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 65 and 84 years old

Weight ≥ 110 pounds

Must not have

Have history of degenerative disease of the nervous system such as dementia and Alzheimer's

Currently have active cancer treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using special air filters in homes can help people with heart disease by cleaning the air they breathe. The goal is to see if reducing indoor air pollution can slow down the worsening of their heart condition.

Who is the study for?

Adults aged 65-84 living in Los Angeles County with a history of ischemic heart disease, clinically stable for the past 6 months, and weighing at least 110 pounds can join. Smokers or those with certain health conditions like active cancer treatments or degenerative diseases are excluded.

What is being tested?

The trial is testing if using HEPA air filters in homes can slow down the worsening of atherothrombosis (blood clotting in hardened arteries) compared to sham (fake) filters by reducing fine particle pollution indoors.

What are the potential side effects?

Since this trial involves indoor air filtration systems, there are no direct medical side effects expected from participating. However, any unexpected reactions to the equipment will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 65 and 84 years old.

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I weigh at least 110 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a degenerative nervous system condition like dementia or Alzheimer's.

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I am currently undergoing treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the baseline, in the middle (4.5 month after intervention) and immediately after each of the 9-month interventions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in P-selectin

Change in augmentation index

Change in blood pressure

+2 more

Secondary study objectives

Change in C-reactive protein

Change in fasting glucose

Change in fasting insulin

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham first and HEPAExperimental Treatment2 Interventions

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.

Group II: HEPA first and shamExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HEPA filtration

2009

N/A

~50

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Indoor air filtration systems work by removing fine particulate matter (PM2.5) from the air, which can penetrate deep into the lungs and enter the bloodstream. These systems typically use high-efficiency particulate air (HEPA) filters to trap particles as small as 0.3 microns. Reducing PM2.5 exposure is crucial for patients with ischemic heart disease because these particles can exacerbate cardiovascular conditions by promoting inflammation and atherothrombosis. By lowering indoor PM2.5 levels, air filtration can help slow the progression of atherothrombosis, thereby potentially reducing the risk of heart attacks and other cardiovascular events.