Effect of Woodsmoke on Vascular Function (FIREWOOD)
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| First Received Date ICMJE | October 11, 2011 | ||||||||||||||||||||
| Last Updated Date | January 23, 2013 | ||||||||||||||||||||
| Start Date ICMJE | September 2011 | ||||||||||||||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators [ Time Frame: 4-6 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 NCT01495325 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Effect of Woodsmoke on Vascular Function | ||||||||||||||||||||
| Official Title ICMJE | Effect of Woodsmoke on Vascular Function in Healthy Firefighters | ||||||||||||||||||||
| Brief Summary | Exposure to air pollution is a well established risk factor for the development of heart disease. Firefighters are exposed to excess air pollution in the form of wood smoke during the extinguishing of forest or woodland fires. Heart attacks in on-duty firefighters have been linked to specific duties and in particular fire suppression, but the reasons for this increase in risk are not well understood. Exposure to wood smoke may alter blood vessel function and increase blood clot formation to explain the link between fire suppression and heart attacks. The investigators wish to determine the effect of exposure to wood smoke at concentrations found at the perimeter of a woodland fire on blood vessel function and clotting in healthy non-smoking male professional firefighters or volunteers. Volunteers will be studied before and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body exposure chamber. The investigators will perform comprehensive vascular assessments thereafter. Understanding the effects of wood smoke on the blood vessels and clotting will be an important first step in helping to protect firefighters from heart disease. Through research, the investigators hope to identify methods to minimise the risk of heart attacks in firefighters and understand the health effects of a major source of air pollution that is relevant to the general population. |
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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 | Vascular Function | ||||||||||||||||||||
| Intervention ICMJE |
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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 | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||||||||||
| Estimated Completion Date | January 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||||||||||
| Ages | 18 Years to 35 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01495325 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | 2011-194-31M, PG/11/27/28842 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | University of Edinburgh | ||||||||||||||||||||
| Study Sponsor ICMJE | University of Edinburgh | ||||||||||||||||||||
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| Investigators ICMJE |
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| Information Provided By | University of Edinburgh | ||||||||||||||||||||
| Verification Date | January 2013 | ||||||||||||||||||||
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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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