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

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00745446
First received: September 2, 2008
Last updated: September 4, 2008
Last verified: September 2008

September 2, 2008
September 4, 2008
September 2007
February 2008   (final data collection date for primary outcome measure)
Forearm blood flow in response to infused intra-arterial vasodilators [ Time Frame: 6 hours post-exposure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745446 on ClinicalTrials.gov Archive Site
  • Arterial stiffness measured by applanation tonometry [ Time Frame: In the 1 hour following exposure ] [ Designated as safety issue: No ]
  • Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow [ Time Frame: 2 hours after the exposure ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide - a marker of pulmonary inflammation [ Time Frame: 1 hour & 6 hours after exposure ] [ Designated as safety issue: No ]
  • Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin [ Time Frame: 6 hours after exposure ] [ Designated as safety issue: No ]
  • Biochemical markers of systemic inflammation [ Time Frame: Baseline, 2, 6 & 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Heart Disease
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: 1
    1 hour exposure to filtered air
    Intervention: Procedure: Forearm Venous Occlusion Plethysmography
  • Experimental: 2
    1 hour exposure to diesel exhaust (300mcg/m3)
    Intervention: Procedure: Forearm Venous Occlusion Plethysmography
  • Experimental: 3
    1 hour exposure to filtered diesel exhaust
    Intervention: Procedure: Forearm Venous Occlusion Plethysmography
Lucking AJ, Lundbäck 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Intercurrent illness
  • Smoking
  • Significant occupational exposure to air pollution
  • Regular medication usage
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00745446
VOLVO 3ARM
No
Dr Anders Blomberg, Umeå University
University of Edinburgh
Umeå University
Principal Investigator: Anders Blomberg, MD Umeå University
University of Edinburgh
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP