NCT03744871

Air Pollution: Strategies for Personalized Intervention to Reduce Exposure

ASPIRE: Air Pollution: Strategies for Personalized Intervention to Reduce Exposure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Fine particulate matter \< 2.5 microns (PM2.5) air pollution is a leading global risk factor for cardiovascular morbidity and mortality. PM2.5 presents a serious ongoing public health threat to patients living in highly-polluted countries (ex: China, India) where air quality is projected to remain extremely poor (far exceeding World Health Organization Air Quality Guidelines) for the foreseeable future. This study reviews the benefits of personal level intervention (wearing N95 respirator) over long term, to prevent clinical events among patients with cardiovascular disease.

Detailed description

CLEANAIR-ACS will be an investigation within ASPIRE, that will test the ability of personal-level intervention (N95 respirators) to improve validated surrogate markers of cardio-metabolic health in patients with a recent Acute Coronary Syndrome (ACS). Patients with ACS are a vulnerable patient population with vulnerability and at risk for future cardiovascular events. This vanguard phase study in Beijing involving patients exposed to high levels of air pollution who have recently sustained an ACS event, is necessary to obtain feasibility data and gather a battery of information allowing for the appropriate design of a larger clinical outcome trial. What is more, positive results would provide critically-important information demonstrating for the first time that it is feasible to "prescribe" the use of these personal protection devices to cardiac patients, and that their usage is capable of translating into demonstrable health benefits (i.e., improved BP and insulin sensitivity) over the long-term. The study hypothesis is that long-term personal-level interventions to reduce exposure to PM2.5 can be feasibly performed for 1-year post-acute coronary syndrome (ACS) and will result in significant improvements in validated surrogate cardiometabolic endpoints predictive of morbidity/mortality.

Conditions

• Air Pollution

Interventions

Type	Name	Description
OTHER	N95 Respirator	SiTi N95 respirator with microventilator (change twice weekly and earlier as needed).

Timeline

• Start date: 2019-03-22
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2018-11-16
• Last updated: 2023-12-04

Locations

2 sites across 2 countries: United States, China