Status:
COMPLETED
Ozone Cardiovascular Effects in Genetically Susceptible People
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conservation of Clean Air and Water in Europe (CONCAWE)
Conditions:
Healthy
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Increases in air pollution are associated with increases in deaths from cardiovascular disease, but the investigators know little about how ozone air pollution affects the cardiovascular system. The i...
Eligibility Criteria
Inclusion
- Healthy,
- Never-smokers with normal spirometry based on the standards published by Morris and co-workers (Morris et al. 1971), and
- A normal electrocardiogram. -
Exclusion
- Any history of habitual smoking.
- Marijuana smoking within the past 5 years.
- Pregnancy.
- Any history of significant organ impairment, chronic respiratory disease, ischemic heart disease, active psychiatric disorder or current drug or alcohol abuse.
- Occupation involving regular, heavy dust or particle exposure, such as welding, mining, foundry work.
- FEV1 \< 75% of predicted at baseline screening.
- Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
- Subjects on certain prescription medications such as prednisone or statins will be excluded. Use of other medications will be considered on an individual basis. Subjects will not be asked to discontinue prescription medications for the purposes of this study.
- Hypertension (blood pressure higher than 140/90 mmHg or on antihypertensive medication).
- Subject lives outside the Rochester metropolitan area.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01192477
Start Date
May 1 2011
End Date
August 1 2012
Last Update
December 4 2013
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642