Ozone Cardiovascular Effects in Genetically Susceptible People (OZCARD)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Ozone

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nitric oxide bioavailability	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.	Before and 3 hours after ozone exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of endothelial injury	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.	Before and 3 hours after ozone exposure

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Environmental Health Sciences (NIEHS); Exxon Mobil; Conservation of Clean Air and Water in Europe (CONCAWE)
• Investigators: Principal Investigator: Mark Frampton, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Air pollution; Ozone; Health effects of ozone exposure
• Other Study ID Numbers: 017428; R01ES017428-01A1 (U.S. NIH Grant/Contract)