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Cardiovascular Effects of Aerosols in Residences Study (CLEAR)

Primary Purpose

Endothelial Dysfunction, Systemic Inflammation

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
HEPA Filter
HEPA Filtration Placebo
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endothelial Dysfunction focused on measuring Inflammation, Pathologic Processes

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Simon Fraser University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Indoor Air HEPA Filtration

HEPA Filtration Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in reactive hyperemia measurement after HEPA filtration
Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).

Secondary Outcome Measures

Difference in C-Reactive Protein after HEPA Filtration
Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).

Full Information

First Posted
March 15, 2012
Last Updated
April 10, 2014
Sponsor
Simon Fraser University
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1. Study Identification

Unique Protocol Identification Number
NCT01570062
Brief Title
Cardiovascular Effects of Aerosols in Residences Study
Acronym
CLEAR
Official Title
Subclinical Cardiovascular Health Benefits of Interventions to Reduce Exposure to Combustion-Derived Particulate Air Pollution
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Systemic Inflammation
Keywords
Inflammation, Pathologic Processes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indoor Air HEPA Filtration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HEPA Filtration Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
HEPA Filter
Other Intervention Name(s)
Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
HEPA Filtration Placebo
Other Intervention Name(s)
Living area HEPA: Honeywell, Model 50250, Bedroom HEPA: Honeywell, Model 18155
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in reactive hyperemia measurement after HEPA filtration
Description
Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
Time Frame
after 1 week of filtration
Secondary Outcome Measure Information:
Title
Difference in C-Reactive Protein after HEPA Filtration
Description
Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
Time Frame
after 1 week of filtration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Allen, PhD
Organizational Affiliation
Simon Fraser University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Fraser University
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5A 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21257787
Citation
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.
Results Reference
background
PubMed Identifier
25896330
Citation
Kajbafzadeh M, Brauer M, Karlen B, Carlsten C, van Eeden S, Allen RW. The impacts of traffic-related and woodsmoke particulate matter on measures of cardiovascular health: a HEPA filter intervention study. Occup Environ Med. 2015 Jun;72(6):394-400. doi: 10.1136/oemed-2014-102696. Epub 2015 Apr 20.
Results Reference
derived

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Cardiovascular Effects of Aerosols in Residences Study

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