The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution
This study is not yet open for participant recruitment.
Verified August 2012 by University of Edinburgh
Sponsor:
University of Edinburgh
Collaborators:
NHS Lothian
Umeå University
Information provided by (Responsible Party):
Jeremy Langrish, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00845169
First received: February 17, 2009
Last updated: August 3, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 17, 2009 | ||||||||
| Last Updated Date | August 3, 2012 | ||||||||
| Start Date ICMJE | April 2012 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Forearm blood flow measured by venous occlusion plethysmography during intraarterial infusion of nitric oxide synthase inhibitors L-NMMA, SMTC and 1400W and positive control norepinephrine. [ Time Frame: 2-4 hours after exposure ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00845169 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Plasma nitrite concentration [ Time Frame: During forearm study ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution | ||||||||
| Official Title ICMJE | The Role of Nitric Oxide Synthase Isoforms in the Cardiovascular Effects of Air Pollution | ||||||||
| Brief Summary | Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide synthase isoforms (NO) in the adverse vascular responses observed following exposure to diesel exhaust. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Endothelial Dysfunction | ||||||||
| Intervention ICMJE | Procedure: Forearm vascular study
Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of nitric oxide synthase inhibitors L-NMMA (2-8 µg/min), S-methionyl-L-citrulline (25-200 nmol/min) and 1400W (100-1000 nmol/min) and positive control norepinephrine (60-540 pmol/min)
Other Names:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 16 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00845169 | ||||||||
| Other Study ID Numbers ICMJE | DNR 08-185M/2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jeremy Langrish, University of Edinburgh | ||||||||
| Study Sponsor ICMJE | University of Edinburgh | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Edinburgh | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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