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Ozone Cardiovascular Effects in Genetically Susceptible People

NCT01192477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Conservation of Clean Air and Water in Europe (CONCAWE)

    collaborator UNKNOWN

  • Exxon Mobil

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • Mark Frampton, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192477 on ClinicalTrials.gov