Status:
UNKNOWN
Cardiovascular Effects of Exposure to Ozone
Lead Sponsor:
Health Effects Institute
Collaborating Sponsors:
Carelon Research
University of California, San Francisco
Conditions:
Cardiovascular Injury
Eligibility:
All Genders
55-70 years
Brief Summary
The Multicenter Ozone Study in Elderly Subjects will investigate whether short-term exposure of elderly volunteers to ambient levels of ozone in a controlled exposure setting causes acute cardiovascul...
Detailed Description
This multicenter study will investigate whether short-term exposure of elderly volunteers to ambient levels of O3 in a controlled exposure setting while intermittently exercising causes acute cardiova...
Eligibility Criteria
Inclusion
- males and females of all ethnic backgrounds.
- Normal spirometry (FEV1 and FVC \>75% of predicted and FEV1/FVC \>0.65).
- Ability to complete the exposure exercise regimen chosen to induce a ventilation rate of 15 to 17 L/min/m2 without exceeding 80% of predicted maximal heart rate.
- Normal baseline 12-lead resting ECG, and absence of significant ST depression while performing the 15-minute required level of exercise targeted for the exposure period.
- Subjects must be able to avoid certain medication supplements listed for 1 week before the exposure.
Exclusion
- Non-English speaking.
- Including, but not limited to as ascertained by the physicians: Subjects with chronic cardiovascular (such as ischemic heart disease) or respiratory (such as asthma or COPD) disease; diabetes, or other organ or system dysfunction; cerebrovascular disease; active psychiatric disorders that would interfere with the subject's ability to understand and participate in the study. Subjects who have tested positive for a disease that affects the immune system (such as HIV, lymphoma, leukemia) or current drug or alcohol abuse (defined as having more than 3 drinks per day or being unable to abstain from alcohol for 3 days).
- Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
- Ever-smokers (smoked tobacco or marijuana during the last five years, or with history of \>10 pack year for tobacco or \> 1 joint year for marijuana, or living with a smoker who smokes inside the house).
- Subject having plasma cotinine level \> 3ng/mL.
- BMI \>35 or \<18 (35 is the official cut off for class 1 obesity).
- Hypertension (defined as blood pressure \>140 systolic or \>90diastolic) or on anti-hypertension medications other than diuretics.
- Pregnancy or nursing (breastfeeding).
- On the following medications: prednisone, statins, beta-blockers, anticoagulants, current hormonal therapy, tamoxifen. Subjects will not be asked to discontinue needed prescription medications for the purpose of this study. If any of these medications becomes necessary during the course of the study, the subjects will be excluded. Use of other medications will be considered on an individual basis.
- Subjects taking aspirin or PDE5 inhibitors must be willing to abstain from these medications during the week preceding each exposure.
- Occupational exposures (exposed to high levels of vapors, dust, gases, or fumes on an on-going basis)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01487005
Start Date
January 1 2012
End Date
December 1 2014
Last Update
June 11 2012
Active Locations (4)
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1
University of California at San Francisco
San Francisco, California, United States, 94143
2
New England Research Institutes, Inc.
Watertown, Massachusetts, United States, 02472
3
University of Rochester
Rochester, New York, United States, 14642
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599