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Reducing PM-associated CV Health Effects for Seniors

2020年10月20日 更新者:Masako Morishita、Michigan State University

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.

We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.

Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.

The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.

研究概览

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

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

50年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 50 to 85 years old
  • non-smoking healthy adults

Exclusion Criteria:

  • smoke or anyone in your residence smokes.
  • had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
  • have renal disease requiring dialysis.
  • have had medication changes in the past 6 weeks.
  • use supplementary oxygen.

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
假比较器:Sham
Participants were exposed to unfiltered ambient air (sham) filtered air using air filtration systems in the bedroom and main living space of each residence.
Subjects were exposed to unfiltered air.
有源比较器:Low efficiency
Participants were exposed to low-efficiency (LE) "HEPA-type" filtered air using air filtration systems in the bedroom and main living space of each residence.
Subjects were exposed to low-efficiency filtered air.
有源比较器:High efficiency
Participants were exposed to high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.
Subjects were exposed to high-efficiency filtered air.

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
brachial blood pressure
大体时间:at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Brachial blood pressure was measured using a BPTru device.
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

次要结果测量

结果测量
措施说明
大体时间
noninvasive aortic hemodynamics
大体时间:at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Aortic hemodynamics was measured using a SphygmoCor device.
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Pulse wave velocity
大体时间:at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Pulse wave velocity was measured using a SphygmoCor device.
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
heart rate variability
大体时间:at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Heart rate variability was measured using a SphygmoCor device.
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
microvasculature tone
大体时间:at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Retinal photography was used to measure retinal arteriole diameters.
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2014年10月21日

初级完成 (实际的)

2016年11月4日

研究完成 (实际的)

2016年11月4日

研究注册日期

首次提交

2017年11月3日

首先提交符合 QC 标准的

2017年11月3日

首次发布 (实际的)

2017年11月7日

研究记录更新

最后更新发布 (实际的)

2020年10月22日

上次提交的符合 QC 标准的更新

2020年10月20日

最后验证

2020年10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

  • R01NR014484 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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