OZCARD: Ozone Cardiovascular Effects in Genetically Susceptible People

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01192477
• Collaborator: National Institute of Environmental Health Sciences (NIEHS) (NIH), Conservation of Clean Air and Water in Europe (CONCAWE) (Other), Exxon Mobil (Industry)
• Enrollment: 80
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Healthy	Other: Ozone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Ozone Cardiovascular Effects in Genetically Susceptible People
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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: Ozone exposure Ozone air pollution
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: Ozone exposure Ozone air pollution
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: Ozone exposure Ozone air pollution

Outcome Measures

Primary Outcome Measures

1. Nitric oxide bioavailability [Before and 3 hours after ozone exposure]

   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

1. Evidence of endothelial injury [Before and 3 hours after ozone exposure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute of Environmental Health Sciences (NIEHS)
• Conservation of Clean Air and Water in Europe (CONCAWE)
• Exxon Mobil

Investigators

• Principal Investigator: Mark Frampton, MD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Frampton, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01192477
• Other Study ID Numbers: 017428; R01ES017428-01A1
• First Posted: Sep 1, 2010
• Last Update Posted: Dec 4, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Mark Frampton, Professor, University of Rochester: Air pollution; Ozone; Health effects of ozone exposure

Study Results

No Results Posted as of Dec 4, 2013