Clinical trial NCT03334565: Reducing PM-associated CV Health Effects for Seniors
Official title: Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases in Old Age
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2017-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: brachial blood pressure
timeFrame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Secondary outcomes:
measure: noninvasive aortic hemodynamics
timeFrame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
measure: Pulse wave velocity
timeFrame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
measure: heart rate variability
timeFrame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
measure: microvasculature tone
timeFrame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Other outcomes:
Locations:
Study officials:
References:
citation: Morishita M, Adar SD, D'Souza J, Ziemba RA, Bard RL, Spino C, Brook RD. Effect of Portable Air Filtration Systems on Personal Exposure to Fine Particulate Matter and Blood Pressure Among Residents in a Low-Income Senior Facility: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1350-1357. doi: 10.1001/jamainternmed.2018.3308.