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Cardiovascular Effects of Aerosols in Residences Study (CLEAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ryan Allen, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01570062
First received: March 15, 2012
Last updated: April 10, 2014
Last verified: April 2014

March 15, 2012
April 10, 2014
November 2011
August 2012   (final data collection date for primary outcome measure)
Difference in reactive hyperemia measurement after HEPA filtration [ Time Frame: after 1 week of filtration ] [ Designated as safety issue: No ]
Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
Same as current
Complete list of historical versions of study NCT01570062 on ClinicalTrials.gov Archive Site
Difference in C-Reactive Protein after HEPA Filtration [ Time Frame: after 1 week of filtration ] [ Designated as safety issue: No ]
Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
Same as current
Not Provided
Not Provided
 
Cardiovascular Effects of Aerosols in Residences Study
Subclinical Cardiovascular Health Benefits of Interventions to Reduce Exposure to Combustion-Derived Particulate Air Pollution

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Endothelial Dysfunction
  • Systemic Inflammation
  • Device: HEPA Filter
    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
  • Device: HEPA Filtration Placebo
    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
  • Active Comparator: Indoor Air HEPA Filtration
    HEPA filters will be placed in participant's main living area and bedroom. Actual filtration will occur during only one of the two 7-day sampling periods.
    Intervention: Device: HEPA Filter
  • Placebo Comparator: HEPA Filtration Placebo
    For one of two 7-day sampling sessions, HEPA filters placed in participants' homes will be run without an actual filter in the housing unit.
    Intervention: Device: HEPA Filtration Placebo
Allen RW, Carlsten C, Karlen B, Leckie S, van Eeden S, Vedal S, Wong I, Brauer M. An air filter intervention study of endothelial function among healthy adults in a woodsmoke-impacted community. Am J Respir Crit Care Med. 2011 May 1;183(9):1222-30. doi: 10.1164/rccm.201010-1572OC. Epub 2011 Jan 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01570062
Allen,R-MOP111042
Yes
Ryan Allen, Simon Fraser University
Simon Fraser University
Not Provided
Principal Investigator: Ryan Allen, PhD Simon Fraser University, Canada
Simon Fraser University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP