Ozone Cardiovascular Effects in Genetically Susceptible People

NCT ID: NCT01192477

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-08-31

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.

Conditions

Healthy

Keywords

Air pollution; Ozone; Health effects of ozone exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Ozone 0.1 ppm

Group Type: EXPERIMENTAL

Ozone

Intervention Type: OTHER

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.

Ozone 0.2 ppm

Group Type: EXPERIMENTAL

Ozone

Intervention Type: OTHER

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.

Filtered air

Group Type: SHAM_COMPARATOR

Ozone

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Ozone exposure; Ozone air pollution

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Conservation of Clean Air and Water in Europe (CONCAWE)

UNKNOWN

Sponsor Role: collaborator

Exxon Mobil

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Mark Frampton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Frampton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

R01ES017428-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

017428

Identifier Type: -

Identifier Source: org_study_id