NCT05454930

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
5.6 years until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

July 31, 2015

Last Update Submit

July 8, 2022

Conditions

Cardiovascular Diseases

Keywords

air pollutiontrafficvascular functiongasoline exhaustdiesel exhaust

Outcome Measures

Primary Outcomes (4)

  • Change in Brachial Artery Diameter from Pre-Drive to Post-Drive

    Ultrasound assessment of brachial artery diameter, in millimeters.

    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

    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

    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

    30 minutes before 120 minute driving session; 30 minutes, 5 hour, and 24 hours post-driving session

Secondary Outcomes (4)

  • circulating stress hormone

    30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session

  • complete blood count with differential

    30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session

  • inflammatory marker interleukin-6

    30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session

  • inflammatory marker c-reactive protein

    30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session

Study Arms (2)

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

Other: Filtered Air

Interventions

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

Typical Commute, Filtered Air

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

  • asthma,
  • high blood pressure,
  • diabetes,
  • high cholesterol,
  • other chronic conditions requiring ongoing medical care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 38011704DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Joel Kaufman, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Environmental & Occupational Health Sciences

Study Record Dates

First Submitted

July 31, 2015

First Posted

July 12, 2022

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

US(1)