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

Not Applicable

Completed

• Conditions: Heart Disease
• Interventions: Procedure: Forearm Venous Occlusion Plethysmography

• Registration Number: NCT00745446
• Lead Sponsor: University of Edinburgh

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-09
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Last Update Submitted: 2008-09-04
• Last Update Posted: 2008-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• Healthy male volunteers

Exclusion Criteria

• Intercurrent illness
• Smoking
• Significant occupational exposure to air pollution
• Regular medication usage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Forearm Venous Occlusion Plethysmography	1 hour exposure to filtered air
2	Forearm Venous Occlusion Plethysmography	1 hour exposure to diesel exhaust (300mcg/m3)
3	Forearm Venous Occlusion Plethysmography	1 hour exposure to filtered diesel exhaust

Primary Outcome Measures

Name	Time	Method
Forearm blood flow in response to infused intra-arterial vasodilators	6 hours post-exposure

Secondary Outcome Measures

Name	Time	Method
Arterial stiffness measured by applanation tonometry	In the 1 hour following exposure
Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow	2 hours after the exposure
Exhaled nitric oxide - a marker of pulmonary inflammation	1 hour & 6 hours after exposure
Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin	6 hours after exposure
Biochemical markers of systemic inflammation	Baseline, 2, 6 & 24 hours

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Västerbottens, Sweden