- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805063
Effect of Fire Suppression and Emergency Duties on Vascular Function
Effect of Fire Suppression and Emergency Duties on Vascular Function in Firefighters
Firefighters are at increased risk of death from heart attacks when compared to other emergencyy service professionals whose jobs involve similar components such as emergency call-outs and shift work. In the largest analysis of cause of death amongst on-duty firefighters, firefighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire suppression whilst this activity represented a relatively small amount of a firefighters professional time. There was also a risk of death associated with other duties such as emergency non-fire response and physical exertion.
The investigators hypothesize that participation in active fire-fighting duties impairs blood vessel function and increases blood clot formation when compared with non-fire-fighting activities. In this study, healthy career firefighters will be assessed after three periods of duty: fire-suppression, emergency response without fire suppression and following a sedentary shift. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess blood vessel function following these duties. By undertaking this comprehensive assessment of blood, blood vessel and heart function the investigators hope to understand the mechanisms whereby the risk of a heart attack, fatal or otherwise, is posed throughout these distinct duties that firefighters undertake on a daily basis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amanda L Hunter, MBChB
- Phone Number: +441312426437
- Email: amanda.hunter@ed.ac.uk
Study Contact Backup
- Name: Nicholas L Mills, MBChB PhD
- Phone Number: +441312426437
- Email: nick.mills@ed.ac.uk
Study Locations
-
-
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Edinburgh, United Kingdom, EH16 4SA
- Recruiting
- Royal Infirmary of Edinburgh Clinical Research Facility
-
Contact:
- Amanda L Hunter, MBChB
- Phone Number: +441312426437
- Email: amanda.hunter@ed.ac.uk
-
Contact:
- Nicholas L Mills, MBChB PhD
- Phone Number: +441312426437
- Email: nick.mills@ed.ac.uk
-
Principal Investigator:
- Amanda L Hunter, MBChB
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Non-smoking healthy firefighters
Exclusion Criteria:
- Current smoker
- History of lung or ischaemic heart disease
- Malignant arrhythmia
- Systolic blood pressure >190mmHg or <100mmHg
- Renal or hepatic dysfunction
- Previous history of blood dyscrasia
- Unable to tolerate the supine position
- Blood donation within the last 3 months
- Recent respiratory tract infection within the past 4 weeks
- Routine medication including aspirin and NSAIDs
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Fire suppression
Firefighters will attend for vascular assessments following a night shift where they have performed fire suppression
|
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 µg/min).
Other Names:
Ex-vivo assessment of thrombus formation using the Badimon Chamber
|
Non-fire emergency duty
Firefighters will attend for vascular assessments following a night shift where they have had an emergency response without fire suppression eg.
road traffic collision.
|
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 µg/min).
Other Names:
Ex-vivo assessment of thrombus formation using the Badimon Chamber
|
Sedentary shift
Firefighters will attend for vascular assessments following a night shift where they have remained sedentary throughout the shift.
|
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 µg/min).
Other Names:
Ex-vivo assessment of thrombus formation using the Badimon Chamber
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
Time Frame: up to 12 hours after exposure
|
up to 12 hours after exposure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ex-vivo thrombus formation using the Badimon chamber
Time Frame: up to 12 hours after exposure
|
up to 12 hours after exposure
|
Plasma t-PA and PAI concentrations following infusion of bradykinin
Time Frame: During forearm study, up to 12 hours after exposure
|
During forearm study, up to 12 hours after exposure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David E Newby, MD PhD, University of Edinburgh
- Study Director: Nicholas L Mills, MBChB PhD, University of Edinburgh
- Principal Investigator: Amanda L Hunter, MBChB, University of Edinburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-SS-0049
- PG/11/27/28842 (Other Grant/Funding Number: British Heart Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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