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临床试验/NCT03334565
NCT03334565已完成不适用

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Michigan State University0 个研究点目标入组 40 人开始时间: 2014年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
brachial blood pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

brachial blood pressure

时间窗: 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.

次要结局

  • heart rate variability(at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement)
  • microvasculature tone(at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement)
  • noninvasive aortic hemodynamics(at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement)
  • Pulse wave velocity(at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Masako Morishita

Associate Professor

Michigan State University

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Reducing PM-associated CV Health Effects for Seniors | 临床试验