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

ConditionsAir PollutionAtherosclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-84
SponsorUniversity of Southern California

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: HEPA first and shamExperimental treatment 2 interventions
Group B: Sham first and HEPAExperimental treatment 2 interventions

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Duke University

Collaborator

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Source ClinicalTrials.gov
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