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

NCT ID: NCT00745446

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Heart Disease

Keywords

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Air pollution Diesel exhaust Endothelial function Vascular function Particle trap Thrombosis effects inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

1 hour exposure to filtered air

Group Type EXPERIMENTAL

Forearm Venous Occlusion Plethysmography

Intervention Type PROCEDURE

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

2

1 hour exposure to diesel exhaust (300mcg/m3)

Group Type EXPERIMENTAL

Forearm Venous Occlusion Plethysmography

Intervention Type PROCEDURE

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

3

1 hour exposure to filtered diesel exhaust

Group Type EXPERIMENTAL

Forearm Venous Occlusion Plethysmography

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers

Exclusion Criteria

* Intercurrent illness
* Smoking
* Significant occupational exposure to air pollution
* Regular medication usage
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Umeå University

Principal Investigators

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Anders Blomberg, MD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Umeå University

Umeå, Västerbottens, Sweden

Site Status

Countries

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Sweden

References

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Lucking AJ, Lundback M, Barath SL, Mills NL, Sidhu MK, Langrish JP, Boon NA, Pourazar J, Badimon JJ, Gerlofs-Nijland ME, Cassee FR, Boman C, Donaldson K, Sandstrom T, Newby DE, Blomberg A. Particle traps prevent adverse vascular and prothrombotic effects of diesel engine exhaust inhalation in men. Circulation. 2011 Apr 26;123(16):1721-8. doi: 10.1161/CIRCULATIONAHA.110.987263. Epub 2011 Apr 11.

Reference Type DERIVED
PMID: 21482966 (View on PubMed)

Other Identifiers

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VOLVO 3ARM

Identifier Type: -

Identifier Source: org_study_id