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

University of Edinburgh18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Heart Disease

Interventions

Forearm Venous Occlusion PlethysmographyPROCEDURE

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male volunteers Exclusion Criteria: * Intercurrent illness * Smoking * Significant occupational exposure to air pollution * Regular medication usage

Locations (1)

Umeå University

Umeå, Västerbottens, Sweden

Outcomes

Primary Outcomes

Forearm blood flow in response to infused intra-arterial vasodilators

Time frame: 6 hours post-exposure

Secondary Outcomes

Arterial stiffness measured by applanation tonometry

Time frame: In the 1 hour following exposure

Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow

Time frame: 2 hours after the exposure

Exhaled nitric oxide - a marker of pulmonary inflammation

Time frame: 1 hour & 6 hours after exposure

Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin

Time frame: 6 hours after exposure

Biochemical markers of systemic inflammation

Time frame: Baseline, 2, 6 & 24 hours

Data from ClinicalTrials.gov

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