Cardiovascular Effects of Exposure to Ozone
Status unconfirmed
Conditions studied: Cardiovascular Injury
In brief
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 cardiovascular responses as assessed by changes in blood pressure, cardiac function, and systemic biomarkers of inflammation, endothelial dysfunction, and thrombosis.
Key facts
- Study ID
- NCT01487005
- Run by
- Health Effects Institute
- People needed
- 90
- Starts
- 2012-01-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2012-06-11
Who can join
Age: 55 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of California at San Francisco — San Francisco, California, United States (enrolling)
- University of Rochester — Rochester, New York, United States (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
- New England Research Institutes, Inc. — Watertown, Massachusetts, United States
Full record on ClinicalTrials.gov
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