Cardiovascular EffectsCVDTRAP4NCT01508637
Diesel Exhaust and Vascular Function
A study testing Diesel Exhaust, Filtered Air and Terazosin in people with Cardiovascular Effects, run by University of Washington at 1 site in United States.
Trial summary
Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Effects
- What is being tested?
- Diesel Exhaust, Filtered Air and Terazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2015
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy without chronic illness
- Body Mass Index 18.5 - 26.0
- tolerates 2 mg terazosin dose without unacceptable symptoms
- able to return for four exposure sessions
Who cannot join
- any chronic disease
- tobacco user
- asthma
- elevated cholesterol
- obesity
- hypertension
Show all 9Show fewer
- diabetes
- any chronic cardiovascular or pulmonary disease
- pregnancy or unwillingness to use effective contraception, if female
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Effect of Diesel Exhaust Exposures on Vascular Function in Humans: The Role of Sympathetic Activation
Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.
- Conditions
- Cardiovascular Effects
- Being tested
- Diesel Exhaust, Filtered Air, Terazosin, placebo
- Keywords
- air pollution, vasoconstriction, blood pressure, diesel exhaust
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diesel ExhaustOther
Freshly generated diesel exhaust, diluted to 300 micrograms/cubic meter. Exposures are two hours in duration.
Filtered AirOther
Sham exposure, identical to conditions of diesel exhaust exposure, but with only air filtered of particles and volatile organic compound gases
TerazosinDrug
2 mg by mouth, 90 minutes prior to exposure initiation
placeboDrug
capsule, identical in appearance to terazosin capsule, by mouth, 30 minutes prior to exposure initiation
| Study group | Role | What they receive |
|---|---|---|
| Diesel Exhaust + Terazosin | Experimental | Not described Receives: Other: Diesel Exhaust; Drug: Terazosin |
| Diesel Exhaust + placebo | Experimental | Not described Receives: Other: Diesel Exhaust; Drug: placebo |
| Filtered Air + terazosin | Sham comparator | Not described Receives: Other: Filtered Air; Drug: Terazosin |
| Filtered air + placebo | Sham comparator | Not described Receives: Other: Filtered Air; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: 30-90 minutes after exposure initiation
Secondary outcomes (1)
Brachial artery diameter
The investigators anticipate vasoconstriction (post-exposure vs. pre-exposure) as observed in this conduit artery in response to exposure to Diesel Exhaust, compared to Filtered Air sham exposure.
Measured: Assessed 30 minutes prior to exposure and 30 minutes post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular EffectsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Environmental Protection Agency (EPA)
- Responsible party
- Principal investigator, Joel Daniel Kaufman, University of Washington
- Investigators
- Joel D Kaufman, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508637
- Sponsor's protocol ID
- 39833-D
- Other IDs
- P50ES015915
- Acronym
- CVDTRAP4
- Status last verified
- Jul 2015
- First submitted
- 5 Jan 2012
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diesel Exhaust Exposures on Vascular Function in Humans: The Role of Sympathetic Activation
- ClinicalTrials.gov ID
- NCT01508637
- Acronym / sponsor ID
- CVDTRAP4 / 39833-D
- Conditions
- Cardiovascular Effects
- Keywords
- air pollution, vasoconstriction, blood pressure, diesel exhaust
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Environmental Protection Agency (EPA)
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jan 2012 (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.
Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diesel Exhaust + Terazosin | Experimental | Other: Diesel Exhaust, Drug: Terazosin |
| Diesel Exhaust + placebo | Experimental | Other: Diesel Exhaust, Drug: placebo |
| Filtered Air + terazosin | Sham comparator | Other: Filtered Air, Drug: Terazosin |
| Filtered air + placebo | Sham comparator | Other: Filtered Air, Drug: placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy without chronic illness
- Body Mass Index 18.5 - 26.0
- tolerates 2 mg terazosin dose without unacceptable symptoms
- able to return for four exposure sessions
Key exclusion criteria (9 listed)
- any chronic disease
- tobacco user
- asthma
- elevated cholesterol
- obesity
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 |
|---|---|---|
| Diesel ExhaustFreshly generated diesel exhaust, diluted to 300 micrograms/cubic meter. Exposures are two hours in duration. | Other | Diesel Exhaust + Terazosin, Diesel Exhaust + placebo |
| Filtered AirSham exposure, identical to conditions of diesel exhaust exposure, but with only air filtered of particles and volatile organic compound gases | Other | Filtered Air + terazosin, Filtered air + placebo |
| Terazosin2 mg by mouth, 90 minutes prior to exposure initiation | Drug | Diesel Exhaust + Terazosin, Filtered Air + terazosin |
| placebocapsule, identical in appearance to terazosin capsule, by mouth, 30 minutes prior to exposure initiation | Drug | Diesel Exhaust + placebo, Filtered air + placebo |
Primary outcome
Systolic Blood Pressure
Time frame: 30-90 minutes after exposure initiation
1 secondary outcome
Brachial artery diameter
Time frame: Assessed 30 minutes prior to exposure and 30 minutes post-exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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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.
Joel D Kaufman, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diesel Exhaust, Filtered Air and Terazosin in people with Cardiovascular Effects, run by University of Washington 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Jansen, M.S. (206-616-6525, cvd1trap@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 30-90 minutes after exposure initiation). 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 3 Aug 2015.