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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745446
First Posted: September 3, 2008
Last Update Posted: September 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Umeå University
Information provided by:
University of Edinburgh
  Purpose
The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

Condition Intervention
Heart Disease Procedure: Forearm Venous Occlusion Plethysmography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Forearm blood flow in response to infused intra-arterial vasodilators [ Time Frame: 6 hours post-exposure ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Intercurrent illness
  • Smoking
  • Significant occupational exposure to air pollution
  • Regular medication usage
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745446


Locations
Sweden
Umeå University
Umeå, Västerbottens, Sweden, SE-901 87
Sponsors and Collaborators
University of Edinburgh
Umeå University
Investigators
Principal Investigator: Anders Blomberg, MD Umeå University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Anders Blomberg, Umeå University
ClinicalTrials.gov Identifier: NCT00745446     History of Changes
Other Study ID Numbers: VOLVO 3ARM
First Submitted: September 2, 2008
First Posted: September 3, 2008
Last Update Posted: September 5, 2008
Last Verified: September 2008

Keywords provided by University of Edinburgh:
Air pollution
Diesel exhaust
Endothelial function
Vascular function
Particle trap
Thrombosis
effects
inhalation

Additional relevant MeSH terms:
Heart Diseases
Respiratory Aspiration
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes