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Completed

NCT Number: NCT01570062

Cardiovascular Effects of Aerosols in Residences Study

This study is focused on the effects of HEPA filtration to reduce exposures to combustion-derived air pollution (CDAP). Specifically, the study will evaluate the health benefits of HEPA filters and compare the cardiovascular toxicity of two major sources of CDAP, specifically traffic and residential wood combustion.

Specifically, the purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and air pollution indoors and to improve subclinical indicators of microvascular function and systemic inflammation among healthy adult participants.

The investigators hypothesize that HEPA filter use will help decrease indoor concentrations of CDAP thereby helping to mitigate the associated cardiovascular risks.

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Key information

Conditions

Endothelial Dysfunction Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

About this study

To address knowledge gaps about health risks of specific pollution sources and to provide new evidence on the health benefits of air pollution interventions, the objectives of this study are: 1) quantify the relationship between low-level exposures to combustion-derived PM air pollution and subclinical indicators of cardiovascular disease risk; and 2) compare the relative impact of HEPA filtration for two major PM sources (traffic and residential wood combustion) on these indicators.

The use of HEPA filters may help to mitigate cardiovascular risks factors caused by combustion-derived air pollution (CDAP), (specifically woodstove and traffic emissions). We hypothesize that HEPA filter use and improved woodstove technology will help decrease indoor occurrences of CDAP. This project will help address knowledge gaps in CDAP-related health risks and benefits of interventions. Specific objectives include establishing a relationship between exposure to CDAP and biomarkers of cardiovascular risk and evaluating the impact of HEPA filter use towards improved indoor air quality and health indicators.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19 years or older
  • non-smoking household
  • lives within study boundaries and in areas of interest

Exclusion criteria

  • COPD
  • asthma
  • diabetes
  • heart disease
  • hypertension
  • arthritis
  • gum disease
  • occupationally exposed to traffic exposures &/or woodsmoke
  • if female, pregnant

Treatment and study plan

HEPA Filter

Device

Two HEPA filters will be placed in participant's homes (one in the bedroom and one in the main living area); each HEPA will run for 2 consecutive 7-day sampling sessions. During one of the 7-day sampling sessions, the HEPA filter will run without the internal filter in place (i.e., "placebo" filtration).

Other names: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155

HEPA Filtration Placebo

Device

for one of the two 7-day sampling sessions, both HEPA filters placed in participants' homes will be run without the actual filter in the housing unit.

Other names: Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155

Primary outcomes

  1. Difference in reactive hyperemia measurement after HEPA filtration

    Time frame: after 1 week of filtration

    Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).

Secondary outcomes

  1. Difference in C-Reactive Protein after HEPA Filtration

    Time frame: after 1 week of filtration

    Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Registry information

Official study title

Subclinical Cardiovascular Health Benefits of Interventions to Reduce Exposure to Combustion-Derived Particulate Air Pollution

Acronym: CLEAR

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Apr 14, 2014

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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