Ozone Cardiovascular Effects in Genetically Susceptible People (OZCARD)

This study has been completed.
Sponsor:
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: December 2, 2013
Last verified: December 2013
  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
Study Completion Date: August 2012
Primary Completion Date: August 2012 (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:
  • 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

  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: December 2, 2013
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 April 23, 2014