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

Primary Purpose

Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Forearm Venous Occlusion Plethysmography

About this trial

This is an interventional basic science trial for Heart Disease focused on measuring Air pollution, Diesel exhaust, Endothelial function, Vascular function, Particle trap, Thrombosis, effects, inhalation

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male volunteers

Exclusion Criteria:

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

Sites / Locations

Umeå University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

1 hour exposure to filtered air

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

1 hour exposure to filtered diesel exhaust

Outcomes

Primary Outcome Measures

Forearm blood flow in response to infused intra-arterial vasodilators

Secondary Outcome Measures

Arterial stiffness measured by applanation tonometry

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

Exhaled nitric oxide - a marker of pulmonary inflammation

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

Biochemical markers of systemic inflammation

Full Information

NCT ID

NCT00745446

First Posted

September 2, 2008

Last Updated

September 4, 2008

Sponsor

University of Edinburgh

Collaborators

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT00745446

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Edinburgh

Collaborators

Umeå University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

1 hour exposure to filtered air

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

1 hour exposure to filtered diesel exhaust

Intervention Type

Procedure

Intervention Name(s)

Forearm Venous Occlusion Plethysmography

Intervention Description

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

Primary Outcome Measure Information:

Title

Forearm blood flow in response to infused intra-arterial vasodilators

Time Frame

6 hours post-exposure

Secondary Outcome Measure Information:

Title

Arterial stiffness measured by applanation tonometry

Time Frame

In the 1 hour following exposure

Title

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

Time Frame

2 hours after the exposure

Title

Exhaled nitric oxide - a marker of pulmonary inflammation

Time Frame

1 hour & 6 hours after exposure

Title

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

Time Frame

6 hours after exposure

Title

Biochemical markers of systemic inflammation

Time Frame

Baseline, 2, 6 & 24 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Blomberg, MD

Organizational Affiliation

Umeå University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Umeå University

City

Umeå

State/Province

Västerbottens

ZIP/Postal Code

SE-901 87

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

21482966

Citation

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.

Results Reference

derived

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

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