The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
1 other identifier
interventional
18
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedSeptember 5, 2008
September 1, 2008
5 months
September 2, 2008
September 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forearm blood flow in response to infused intra-arterial vasodilators
6 hours post-exposure
Secondary Outcomes (5)
Arterial stiffness measured by applanation tonometry
In the 1 hour following exposure
Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow
2 hours after the exposure
Exhaled nitric oxide - a marker of pulmonary inflammation
1 hour & 6 hours after exposure
Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin
6 hours after exposure
Biochemical markers of systemic inflammation
Baseline, 2, 6 & 24 hours
Study Arms (3)
1
EXPERIMENTAL1 hour exposure to filtered air
2
EXPERIMENTAL1 hour exposure to diesel exhaust (300mcg/m3)
3
EXPERIMENTAL1 hour exposure to filtered diesel exhaust
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy male volunteers
You may not qualify if:
- Intercurrent illness
- Smoking
- Significant occupational exposure to air pollution
- Regular medication usage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- Umeå Universitycollaborator
Study Sites (1)
Umeå University
Umeå, Västerbottens, SE-901 87, Sweden
Related Publications (1)
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.
PMID: 21482966DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Blomberg, MD
Umeå University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 3, 2008
Study Start
September 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
September 5, 2008
Record last verified: 2008-09