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

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ClinicalTrials.gov Identifier: NCT00745446
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 5, 2008
Sponsor:
Collaborator:
Umeå University
Information provided by:
University of Edinburgh

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

Condition or disease Intervention/treatment Phase
Heart Disease Procedure: Forearm Venous Occlusion Plethysmography Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

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



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

Secondary Outcome Measures :
  1. Arterial stiffness measured by applanation tonometry [ Time Frame: In the 1 hour following exposure ]
  2. Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow [ Time Frame: 2 hours after the exposure ]
  3. Exhaled nitric oxide - a marker of pulmonary inflammation [ Time Frame: 1 hour & 6 hours after exposure ]
  4. Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin [ Time Frame: 6 hours after exposure ]
  5. Biochemical markers of systemic inflammation [ Time Frame: Baseline, 2, 6 & 24 hours ]


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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

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

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 Posted: September 3, 2008    Key Record Dates
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