Cardiovascular Effects of Aerosols in Residences Study (CLEAR)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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British Columbia
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Burnaby、British Columbia、カナダ、V5A 1S6
- Simon Fraser University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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).
他の名前：
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プラセボコンパレーター：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in reactive hyperemia measurement after HEPA filtration
時間枠：after 1 week of filtration
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Participants endothelial function are tested after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
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after 1 week of filtration
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in C-Reactive Protein after HEPA Filtration
時間枠：after 1 week of filtration
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Participants CRP is measured after 1 week of HEPA filtration and after 1 week of non-HEPA filtration (placebo filtration).
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after 1 week of filtration
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ryan Allen, PhD、Simon Fraser University, Canada
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。