The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

Heart Disease Clinical Trial

Official title:

The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745446
• Other study ID #: VOLVO 3ARM
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: September 4, 2008
• Start date: September 2007
• Est. completion date: February 2008

Study information

• Verified date: September 2008
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

Description:

18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.

2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.

Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.

Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.

Blood samples will be collected at timepoints over the 24 hours after exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

• Intercurrent illness

• Smoking

• Significant occupational exposure to air pollution

• Regular medication usage

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Disease

Intervention

Procedure:
• Forearm Venous Occlusion Plethysmography
Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå	Västerbottens

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow in response to infused intra-arterial vasodilators		6 hours post-exposure	No
Secondary	Arterial stiffness measured by applanation tonometry		In the 1 hour following exposure	No
Secondary	Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow		2 hours after the exposure	No
Secondary	Exhaled nitric oxide - a marker of pulmonary inflammation		1 hour & 6 hours after exposure	No
Secondary	Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin		6 hours after exposure	No
Secondary	Biochemical markers of systemic inflammation		Baseline, 2, 6 & 24 hours	No