Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2005-09-30
2006-03-31
Brief Summary
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1. Combustion derived nanoparticulate causes an acute impairment of endothelial vasomotor and fibrinolytic function in healthy volunteers.
2. Exposure to combustion derived air pollution is associated with increased thrombus formation.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Filtered Air Exposure
1 hour exposure to filtered air during intermittent exercise
Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber
Diesel Exhaust Exposure
1 hour exposure to dilute diesel exhaust at a concentration of 300 µg/m3 during intermittent exercise
Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber
Filtered Diesel Exposure
1 hour exposure to diesel exhaust with all particulates filtered out using teflon filter with intermittent exercise
Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber
PALAS Exposure
1 hour exposure to pure carbon particles produced by PALAS generator during intermittent exercise
Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber
Interventions
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Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant occupational exposure to air pollution
* History of lung disease
* Women of child-bearing potential
* Malignant arrhythmias
* Renal or hepatic failure
* Significant co-morbidity
* Systolic blood pressure \>190 or \<100 mmHg
* Previous history of blood dyscrasia
* Unable to tolerate the supine position
* Lack of informed consent
* Blood donation within last 3 months
ALL
Yes
Sponsors
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National Institute for Public Health and the Environment (RIVM)
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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University of Edinburgh
Principal Investigators
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Nicholas L Mills, MB BCh MRCP
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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University of Edinburgh
Edinburgh, , United Kingdom
Countries
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References
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Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.
Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
Other Identifiers
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05/S1103/46
Identifier Type: -
Identifier Source: org_study_id