Reducing PM-associated CV Health Effects for Seniors

Cardiovascular Diseases in Old Age Clinical Trial

Official title:

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334565
• Other study ID #: R01NR014484
• Status: Completed
• Phase: N/A
• Start date: October 21, 2014
• Est. completion date: November 4, 2016

Study information

• Verified date: October 2020
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 4, 2016
• Est. primary completion date: November 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Diseases in Old Age

Intervention

Device:
• Low efficiency air filtration systems
Subjects were exposed to low-efficiency filtered air.
• High efficiency air filtration systems
Subjects were exposed to high-efficiency filtered air.
• Air filtration systems without filters (sham)
Subjects were exposed to unfiltered air.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brachial blood pressure	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
Secondary	noninvasive aortic hemodynamics	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
Secondary	Pulse wave velocity	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
Secondary	heart rate variability	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
Secondary	microvasculature tone	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