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

September 4, 2008 updated by: University of Edinburgh
The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbottens
      • Umeå, Västerbottens, Sweden, SE-901 87
        • Umea University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
1 hour exposure to filtered air
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
Experimental: 2
1 hour exposure to diesel exhaust (300mcg/m3)
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
Experimental: 3
1 hour exposure to filtered diesel exhaust
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forearm blood flow in response to infused intra-arterial vasodilators
Time Frame: 6 hours post-exposure
6 hours post-exposure

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial stiffness measured by applanation tonometry
Time Frame: In the 1 hour following exposure
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
2 hours after the exposure
Exhaled nitric oxide - a marker of pulmonary inflammation
Time Frame: 1 hour & 6 hours after exposure
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
6 hours after exposure
Biochemical markers of systemic inflammation
Time Frame: Baseline, 2, 6 & 24 hours
Baseline, 2, 6 & 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Umeå University

Investigators

  • Principal Investigator: Anders Blomberg, MD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOLVO 3ARM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Disease

Clinical Trials on Forearm Venous Occlusion Plethysmography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe