Cardiovascular DiseasesNCT05454930
Effect of Commute Traffic on Vascular Function
A study testing Filtered Air in people with Cardiovascular Diseases, run by University of Washington at 1 site in United States.
Trial summary
The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Filtered Air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- 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
Who cannot join
- asthma,
- high blood pressure,
- diabetes,
- high cholesterol,
- other chronic conditions requiring ongoing medical care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.
Read the detailed description
In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware of the filtration conditions of the commute on that day. Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area. Before subjects begin the commute trials, they will go through the consent process and a series of screening tests. The study investigators will assess a series of measures regarding vascular function before and after each drive.
- Conditions
- Cardiovascular Diseases
- Being tested
- Filtered Air
- Keywords
- air pollution, traffic, vascular function, gasoline exhaust, diesel exhaust
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtered AirOther
The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter
| Study group | Role | What they receive |
|---|---|---|
| Typical Commute | No intervention | Participants spend two hours in automobile, on heavily trafficked roadways, without active filtration of air pollutants |
| Typical Commute, Filtered Air | Other | Participants spend two hours in automobile, on heavily trafficked roadways, with active filtration of air pollutants Receives: Other: Filtered Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Artery Diameter from Pre-Drive to Post-Drive
Ultrasound assessment of brachial artery diameter, in millimeters.
Measured: 30 minutes before 120 minute driving session; 30 minutes post driving session
Change in Blood Pressure from Pre-Drive to During-Drive and Post-drive
systolic and diastolic blood pressure measured in mmHg
Measured: 10 minutes before driving session; 15, 30, 45, 60, 75, 90, 100, 120 minutes following start of (120 minute) driving session; 10 minutes, 1.5 hours, 3.5 hours, 6 hours, 24 hours after end of driving session.
Change in Retinal Arteriolar Diameter from Pre-Drive to Post-Drive
measured by retinal photography, image analysis, in micrometers
Measured: 30 minutes before 120 minute driving session; 30 minutes post driving session
Gene Expression and DNA methylation
analysis in circulating mononuclear cells; determined via fold change in abundance
Measured: 30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session
Secondary outcomes (4)
circulating stress hormone
cortisol by chemiluminescence (ng/mL)
Measured: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
complete blood count with differential
laboratory values for hematologic indices (cells/uL)
Measured: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
inflammatory marker interleukin-6
interleukin-6 determined by chemiluminescence (pg/mL)
Measured: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
inflammatory marker c-reactive protein
C-reactive protein by immunoturbidimetry (ug/mL)
Measured: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study startJan 2015
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Joel Daniel Kaufman, University of Washington
- Investigators
- Joel Kaufman, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454930
- Sponsor's protocol ID
- STUDY00001196
- Other IDs
- K24ES013195, RD-83479601
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2015
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Young MT, Jansen K, Cosselman KE, Gould TR, Stewart JA, Larson T, Sack C, Vedal S, Szpiro AA, Kaufman JD. Blood Pressure Effect of Traffic-Related Air Pollution : A Crossover Trial of In-Vehicle Filtration. Ann Intern Med. 2023 Dec;176(12):1586-1594. doi: 10.7326/M23-1309. Epub 2023 Nov 28.
PubMed 38011704
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Commute Traffic on Vascular Function
- ClinicalTrials.gov ID
- NCT05454930
- Acronym / sponsor ID
- STUDY00001196
- Conditions
- Cardiovascular Diseases
- Keywords
- air pollution, traffic, vascular function, gasoline exhaust, diesel exhaust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jul 2022 (actual)
- 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.
The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.
Detailed description
In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware of the filtration conditions of the commute on that day. Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area. Before subjects begin the commute trials, they will go through the consent process and a series of screening tests. The study investigators will assess a series of measures regarding vascular function before and after each drive.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Commute | No intervention | –Participants spend two hours in automobile, on heavily trafficked roadways, without active filtration of air pollutants |
| Typical Commute, Filtered Air | Other | Other: Filtered AirParticipants spend two hours in automobile, on heavily trafficked roadways, with active filtration of air pollutants |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (5 listed)
- asthma,
- high blood pressure,
- diabetes,
- high cholesterol,
- other chronic conditions requiring ongoing medical care.
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 |
|---|---|---|
| Filtered AirThe vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter | Other | Typical Commute, Filtered Air |
Primary outcome
Change in Brachial Artery Diameter from Pre-Drive to Post-Drive
Time frame: 30 minutes before 120 minute driving session; 30 minutes post driving session
Ultrasound assessment of brachial artery diameter, in millimeters.
Change in Blood Pressure from Pre-Drive to During-Drive and Post-drive
Time frame: 10 minutes before driving session; 15, 30, 45, 60, 75, 90, 100, 120 minutes following start of (120 minute) driving session; 10 minutes, 1.5 hours, 3.5 hours, 6 hours, 24 hours after end of driving session.
systolic and diastolic blood pressure measured in mmHg
Change in Retinal Arteriolar Diameter from Pre-Drive to Post-Drive
Time frame: 30 minutes before 120 minute driving session; 30 minutes post driving session
measured by retinal photography, image analysis, in micrometers
Gene Expression and DNA methylation
Time frame: 30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session
analysis in circulating mononuclear cells; determined via fold change in abundance
4 secondary outcomes
circulating stress hormone
Time frame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
complete blood count with differential
Time frame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
inflammatory marker interleukin-6
Time frame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
inflammatory marker c-reactive protein
Time frame: 30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
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 12 Jul 2022.
- Derived from this study: PubMed 38011704Young MT, Jansen K, Cosselman KE, Gould TR, Stewart JA, Larson T, Sack C, Vedal S, Szpiro AA, Kaufman JD. Blood Pressure Effect of Traffic-Related Air Pollution : A Crossover Trial of In-Vehicle Filtration. Ann Intern Med. 2023 Dec;176(12):1586-1594. doi: 10.7326/M23-1309. Epub 2023 Nov 28.
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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 Kaufman, MD 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 Filtered Air in people with Cardiovascular Diseases, 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 1 inclusion and 5 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 12 Jul 2022. 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. 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?
Change in Brachial Artery Diameter from Pre-Drive to Post-Drive (time frame: 30 minutes before 120 minute driving session; 30 minutes post driving session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454930, which also lists 1 linked publication.
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 12 Jul 2022.