Effect of Commute Traffic on Vascular Function
2022年7月8日 更新者：Joel Daniel Kaufman、University of Washington
The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.
研究概览
详细说明
In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives.
One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition.
Subjects will be unaware of the filtration conditions of the commute on that day.
Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days.
The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area.
Before subjects begin the commute trials, they will go through the consent process and a series of screening tests.
The study investigators will assess a series of measures regarding vascular function before and after each drive.
研究类型
介入性
注册 (实际的)
16
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Washington
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Seattle、Washington、美国、98195
- University of Washington Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- healthy
Exclusion Criteria:
- asthma,
- high blood pressure,
- diabetes,
- high cholesterol,
- other chronic conditions requiring ongoing medical care.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Typical Commute
Participants spend two hours in automobile, on heavily trafficked roadways, without active filtration of air pollutants
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其他：Typical Commute, Filtered Air
Participants spend two hours in automobile, on heavily trafficked roadways, with active filtration of air pollutants
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The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Brachial Artery Diameter from Pre-Drive to Post-Drive
大体时间：30 minutes before 120 minute driving session; 30 minutes post driving session
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Ultrasound assessment of brachial artery diameter, in millimeters.
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30 minutes before 120 minute driving session; 30 minutes post driving session
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Change in Blood Pressure from Pre-Drive to During-Drive and Post-drive
大体时间：10 minutes before driving session; 15, 30, 45, 60, 75, 90, 100, 120 minutes following start of (120 minute) driving session; 10 minutes, 1.5 hours, 3.5 hours, 6 hours, 24 hours after end of driving session.
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systolic and diastolic blood pressure measured in mmHg
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10 minutes before driving session; 15, 30, 45, 60, 75, 90, 100, 120 minutes following start of (120 minute) driving session; 10 minutes, 1.5 hours, 3.5 hours, 6 hours, 24 hours after end of driving session.
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Change in Retinal Arteriolar Diameter from Pre-Drive to Post-Drive
大体时间：30 minutes before 120 minute driving session; 30 minutes post driving session
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measured by retinal photography, image analysis, in micrometers
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30 minutes before 120 minute driving session; 30 minutes post driving session
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Gene Expression and DNA methylation
大体时间：30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session
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analysis in circulating mononuclear cells; determined via fold change in abundance
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30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
circulating stress hormone
大体时间：30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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cortisol by chemiluminescence (ng/mL)
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30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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complete blood count with differential
大体时间：30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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laboratory values for hematologic indices (cells/uL)
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30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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inflammatory marker interleukin-6
大体时间：30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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interleukin-6 determined by chemiluminescence (pg/mL)
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30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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inflammatory marker c-reactive protein
大体时间：30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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C-reactive protein by immunoturbidimetry (ug/mL)
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30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Joel Kaufman, MD、University of Washington
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年1月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2016年12月1日
研究注册日期
首次提交
2015年7月31日
首先提交符合 QC 标准的
2022年7月8日
首次发布 (实际的)
2022年7月12日
研究记录更新
最后更新发布 (实际的)
2022年7月12日
上次提交的符合 QC 标准的更新
2022年7月8日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00001196
- K24ES013195 (美国 NIH 拨款/合同)
- RD-83479601 (其他赠款/资助编号：US Environmental Protection Agency STAR)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Filtered Air的临床试验
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Ann & Robert H Lurie Children's Hospital of Chicago完全的