Effect of Commute Traffic on Vascular Function

Cardiovascular Diseases Clinical Trial

Official title:

Effect of Commute Traffic on Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454930
• Other study ID #: STUDY00001196
• Secondary ID: K24ES013195RD-83
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• healthy

Exclusion Criteria:

• asthma,

• high blood pressure,

• diabetes,

• high cholesterol,

• other chronic conditions requiring ongoing medical care.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Filtered Air
The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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	circulating stress hormone	cortisol by chemiluminescence (ng/mL)	30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
Secondary	complete blood count with differential	laboratory values for hematologic indices (cells/uL)	30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
Secondary	inflammatory marker interleukin-6	interleukin-6 determined by chemiluminescence (pg/mL)	30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session
Secondary	inflammatory marker c-reactive protein	C-reactive protein by immunoturbidimetry (ug/mL)	30 minutes before 120 minute driving session; 5 hour and 24 hours post-driving session