Air Pollution: Strategies for Personalized Intervention to Reduce Exposure (NCT03744871) | Clinical Trial Compass
CompletedNot Applicable
Air Pollution: Strategies for Personalized Intervention to Reduce Exposure
United States, China30 participantsStarted 2019-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Male or female \>18, able to provide informed consent and willingness to complete the study protocol and measurement procedures, AND
ā. Non-smoker of any type (cigarette, cigar, marijuana) during past six months (100% abstinence per self-report) and living in a non-smoking household (no person living in the household smoking at home) with confirmation of non-smoking status by urinary cotinine levels.
Exclusion criteria
ā. Inability for mental or physical reasons to understand and comply with the informed consent process and/or the study protocol procedures including wearing face mask (i.e: advanced COPD/lung disease requiring use of frequent inhalational or nebulizer treatments) per investigator discretion.
ā. Obesity with arm circumference \>18 inches preventing accurate BP determination during ABPM monitoring
ā. Significant hemodynamically unstable CV disorder including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension. (as further described in Appendix B) at screening
ā. ESRD on dialysis or patients that have received dialysis within 14 days prior to screening
What they're measuring
1
Blood Pressure
Timeframe: 12 months
Trial details
NCT IDNCT03744871
SponsorUniversity Hospitals Cleveland Medical Center