Cardiovascular Effects of Exposure to Ozone (MOSES)
2012年6月8日 更新者：Health Effects Institute
Multicenter Ozone Study in Elderly Subjects
The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes acute cardiovascular responses as assessed by changes in blood pressure, cardiac function, and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.
調査の概要
状態
わからない
条件
詳細な説明
This multicenter study will investigate whether short-term exposure of elderly volunteers to ambient levels of O3 in a controlled exposure setting while intermittently exercising causes acute cardiovascular responses. The study is based on the suppositions that: 1) elderly people are a susceptible group for cardiovascular effects; and 2) effects are more likely with exercise.
The study will involve approximately 90 healthy volunteers aged ≥55 and ≤70 who meet strict criteria for inclusion. They will be exposed for 3 hours to clean air, 0.07 ppm O3 (near the current NAAQS), and 0.12 ppm O3 (a level measured in several locations in the US). A suite of cardiovascular and pulmonary endpoints will be measured on the day before the exposure and up to 22 hours after the exposures. The study is being conducted at three centers using a common protocol and common SOPs. Most the endpoints will be analyzed by core laboratories to reduce the variability in the results. A Data Coordination and Analysis Center will assemble all the data generated by the three centers and conduct the statistical analyses on the combined data sets.
The study has 3 main objectives:
- To determine the relationship of altered autonomic balance (measured as changes in heart rate and heart rate variability (HRV)), cardiac arrhythmia, and repolarization and ozone exposure.
- To identify instances of altered systemic vascular function [measured as brachial artery flow-mediated dilation (FMD)without and with nitroglycerin (NTG) when exposed to ozone.
- To identify pro-thrombotic vascular state (measured as increase in von Willebrand factor antigen in blood - primary endpoints) when exposed to ozone.
Additional objectives include:
- To identify any increase in micro particle-associated tissues factor (measured as number of particles and tissue factor activity) and platelet activation) in ozone exposure.
- To identify if markers of systemic oxidative stress and inflammation and any correlation with the cardiovascular effects and degree of airway injury (measured as CC16) and airway inflammatory effects (neutrophils and cytokines in induced sputum) in ozone exposure.
- To determine if cardiovascular effects in ozone exposure are correlated with airway inflammatory effects, but not lung function effects.
研究の種類
観察的
入学 (予想される)
90
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- 募集
- University of California at San Francisco
-
コンタクト：
- Hofer Wong
- 電話番号：415-206-8951
- メール：howong@sfghoem.ucsf.edu
-
主任研究者：
- John Balmes, MD
-
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Massachusetts
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Watertown、Massachusetts、アメリカ、02472
- 積極的、募集していない
- New England Research Institutes, Inc.
-
-
New York
-
Rochester、New York、アメリカ、14642
- 募集
- University of Rochester
-
コンタクト：
- Erika Little
- 電話番号：585-275-4163
- メール：erika_little@urmc.rochester.edu
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主任研究者：
- Mark Frampton, MD
-
-
North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina at Chapel Hill
-
コンタクト：
- Martha Almond
- 電話番号：919-966-0759
- メール：martha_almond@med.unc.edu
-
主任研究者：
- Philip Bromberg, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
55年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Healthy elderly volunteers living in or around San Francisco, CA, Research Triangle Park, NC, and Rochester, NY
説明
Inclusion Criteria:
- males and females of all ethnic backgrounds.
- Normal spirometry (FEV1 and FVC >75% of predicted and FEV1/FVC >0.65).
- Ability to complete the exposure exercise regimen chosen to induce a ventilation rate of 15 to 17 L/min/m2 without exceeding 80% of predicted maximal heart rate.
- Normal baseline 12-lead resting ECG, and absence of significant ST depression while performing the 15-minute required level of exercise targeted for the exposure period.
- Subjects must be able to avoid certain medication supplements listed for 1 week before the exposure.
Exclusion Criteria:
- Non-English speaking.
- Including, but not limited to as ascertained by the physicians: Subjects with chronic cardiovascular (such as ischemic heart disease) or respiratory (such as asthma or COPD) disease; diabetes, or other organ or system dysfunction; cerebrovascular disease; active psychiatric disorders that would interfere with the subject's ability to understand and participate in the study. Subjects who have tested positive for a disease that affects the immune system (such as HIV, lymphoma, leukemia) or current drug or alcohol abuse (defined as having more than 3 drinks per day or being unable to abstain from alcohol for 3 days).
- Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
- Ever-smokers (smoked tobacco or marijuana during the last five years, or with history of >10 pack year for tobacco or > 1 joint year for marijuana, or living with a smoker who smokes inside the house).
- Subject having plasma cotinine level > 3ng/mL.
- BMI >35 or <18 (35 is the official cut off for class 1 obesity).
- Hypertension (defined as blood pressure >140 systolic or >90diastolic) or on anti-hypertension medications other than diuretics.
- Pregnancy or nursing (breastfeeding).
- On the following medications: prednisone, statins, beta-blockers, anticoagulants, current hormonal therapy, tamoxifen. Subjects will not be asked to discontinue needed prescription medications for the purpose of this study. If any of these medications becomes necessary during the course of the study, the subjects will be excluded. Use of other medications will be considered on an individual basis.
- Subjects taking aspirin or PDE5 inhibitors must be willing to abstain from these medications during the week preceding each exposure.
- Occupational exposures (exposed to high levels of vapors, dust, gases, or fumes on an on-going basis)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
elderly subjects
Healthy
|
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 |
|---|---|---|
|
Change in endothelial function
時間枠：Baseline (16 hours before exposure) and 4 hours after exposure
|
Brachail artey flow-mediated dilation and nitroglycerin-mediated dilation
|
Baseline (16 hours before exposure) and 4 hours after exposure
|
|
Change in heart rate variability
時間枠：Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
|
measured with Holter monitor
|
Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
|
|
Change in prothrombotic vascular state
時間枠：Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
|
Peripheral blood samples will be taken and stored as plasma for measurement of von Willenbrand Factor antigen
|
Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
|
|
Change in cardiac repolarization
時間枠：Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
|
from Holter monitor
|
Baseline (0.5 hours before exposure) and 0.2, 2, and 21.5 after exposure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in markers of systemic inflammation
時間枠：Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
|
Peripheral blood samples will be taken and stored as plasma for measurements of inflammatory markers
|
Baseline (17 hour before exposure) and 3.5 and 22 hours after exposure
|
|
Change in lung function
時間枠：Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
|
Spirometry
|
Baseline (0.2 hours before exposure) and 0.5, 3, and 22.5 hours after exposure
|
|
Lung inflammation
時間枠：22 hours after exposure
|
A sputum sample will be obtained and stored for measurement of inflammatory mediators
|
22 hours after exposure
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Anne Stoddard, PhD、HealthCore-NERI
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Rich DQ, Thurston SW, Balmes JR, Bromberg PA, Arjomandi M, Hazucha MJ, Alexis NE, Ganz P, Zareba W, Thevenet-Morrison K, Koutrakis P, Frampton MW. Do Ambient Ozone or Other Pollutants Modify Effects of Controlled Ozone Exposure on Pulmonary Function? Ann Am Thorac Soc. 2020 May;17(5):563-572. doi: 10.1513/AnnalsATS.201908-597OC.
- Arjomandi M, Balmes JR, Frampton MW, Bromberg P, Rich DQ, Stark P, Alexis NE, Costantini M, Hollenbeck-Pringle D, Dagincourt N, Hazucha MJ. Respiratory Responses to Ozone Exposure. MOSES (The Multicenter Ozone Study in Older Subjects). Am J Respir Crit Care Med. 2018 May 15;197(10):1319-1327. doi: 10.1164/rccm.201708-1613OC.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年1月1日
一次修了 (予想される)
2014年12月1日
研究の完了 (予想される)
2014年12月1日
試験登録日
最初に提出
2011年12月1日
QC基準を満たした最初の提出物
2011年12月5日
最初の投稿 (見積もり)
2011年12月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年6月11日
QC基準を満たした最後の更新が送信されました
2012年6月8日
最終確認日
2012年6月1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。