HealthyOZCARDNCT01192477
Ozone Cardiovascular Effects in Genetically Susceptible People
A study testing Ozone in people with Healthy, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ozone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- Never-smokers with normal spirometry based on the standards published by Morris and co-workers (Morris et al. 1971), and
- A normal electrocardiogram. -
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
- Being tested
- Ozone
- Keywords
- Air pollution, Ozone, Health effects of ozone exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneOther
Also called Ozone exposure, Ozone air pollution
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.
| Study group | Role | What they receive |
|---|---|---|
| Ozone 0.1 ppm | Experimental | Not described Receives: Other: Ozone |
| Ozone 0.2 ppm | Experimental | Not described Receives: Other: Ozone |
| Filtered air | Sham comparator | Not described Receives: Other: Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and 3 hours after ozone exposure
Secondary outcomes (1)
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.
Measured: Before and 3 hours after ozone exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Conservation of Clean Air and Water in Europe (CONCAWE), Exxon Mobil
- Responsible party
- Principal investigator, Mark Frampton, University of Rochester
- Investigators
- Mark Frampton, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192477
- Sponsor's protocol ID
- 017428
- Other IDs
- R01ES017428-01A1
- Acronym
- OZCARD
- Status last verified
- Dec 2013
- First submitted
- 30 Aug 2010
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozone Cardiovascular Effects in Genetically Susceptible People
- ClinicalTrials.gov ID
- NCT01192477
- Acronym / sponsor ID
- OZCARD / 017428
- Conditions
- Healthy
- Keywords
- Air pollution, Ozone, Health effects of ozone exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Conservation of Clean Air and Water in Europe (CONCAWE), Exxon Mobil
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozone 0.1 ppm | Experimental | Other: Ozone |
| Ozone 0.2 ppm | Experimental | Other: Ozone |
| Filtered air | Sham comparator | Other: Ozone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy,
- Never-smokers with normal spirometry based on the standards published by Morris and co-workers (Morris et al. 1971), and
- A normal electrocardiogram. -
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzoneAlso: Ozone exposure, Ozone air pollutionAll 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 | Filtered air, Ozone 0.1 ppm, Ozone 0.2 ppm |
Primary outcome
Nitric oxide bioavailability
Time frame: 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.
1 secondary outcome
Evidence of endothelial injury
Time frame: Before and 3 hours after ozone exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Frampton, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone in people with Healthy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nitric oxide bioavailability (time frame: Before and 3 hours after ozone exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.