Ozone Cardiovascular Effects in Genetically Susceptible People (OZCARD)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Rochester
Collaborators:
Conservation of Clean Air and Water in Europe (CONCAWE)
Exxon Mobil
Information provided by (Responsible Party):
Mark Frampton, University of Rochester
ClinicalTrials.gov Identifier:
NCT01192477
First received: August 30, 2010
Last updated: November 5, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 investigators proposed study will determine the effects of ozone on blood vessel and heart function that could worsen illness in people with underlying heart disease. This will be accomplished by studying healthy volunteers who inhale ozone in a controlled clinical study, and also by studying their exposure to ozone and other pollutants during their normal daily activities. The investigators will study volunteers who may be at increased risk for the effects of ozone because of genetic susceptibility. Understanding the effects of ozone on the heart and circulation can help establish appropriate air pollution standards, and provide strategies to protect the most susceptible people.
| Condition | Intervention |
|---|---|
|
Healthy |
Other: Ozone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Ozone Cardiovascular Effects in Genetically Susceptible People |
Resource links provided by NLM:
Further study details as provided by University of Rochester:
Primary Outcome Measures:
- Nitric oxide bioavailability [ Time Frame: Before and 3 hours after ozone exposure ] [ Designated as safety issue: No ]We hypothesize that systemic vascular effects of exposure to ozone will be reflected in reductions in arterial blood nitrite or its A/V gradient. This will require simultaneous collection of venous and arterial blood.
Secondary Outcome Measures:
- Evidence of endothelial injury [ Time Frame: Before and 3 hours after ozone exposure ] [ Designated as safety issue: No ]We hypothesize that systemic vascular effects of exposure to ozone will alter markers of vascular function and inflammation. Flow cytometry will be used to detect activated platelets and pro-coagulant circulating microparticles.
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ozone 0.1 ppm |
Other: Ozone
All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.
Other Names:
|
| Experimental: Ozone 0.2 ppm |
Other: Ozone
All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.
Other Names:
|
| Sham Comparator: Filtered air |
Other: Ozone
All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192477
Locations
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
University of Rochester
Conservation of Clean Air and Water in Europe (CONCAWE)
Exxon Mobil
Investigators
| Principal Investigator: | Mark Frampton, MD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Mark Frampton, Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01192477 History of Changes |
| Other Study ID Numbers: | 017428, R01ES017428-01A1 |
| Study First Received: | August 30, 2010 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rochester:
|
Air pollution Ozone Health effects of ozone exposure |
ClinicalTrials.gov processed this record on May 19, 2013