- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813032
Comparison of Vascular Function in Emergency Service Professionals (FIRECOP)
Emergency Service Professionals have an increased risk of death from heart attacks when compared to the general public. All the emergency professions share similar responsibilities such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty death amongst fire-fighters accounting for 45% and compared with 22% in police officers and 15% in the general population. The unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure.
In this study the investigators will assess healthy career fire-fighters and age-matched healthy police officer control subjects following a sedentary period. 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 how the blood vessels respond following these duties. The investigators hypothesise that fire-fighters do not have pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of their occupation, but rather these are acute and transitory effects following distinct fire-fighter duties. We therefore expect similar results in both occupational groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh Clinical Research Facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Firefighters
20 firefighters will attend for vascular assessments following a minimum of 48 hours off-duty.
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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
|
|
Police Officers
20 police officers will attend for vascular assessments following a minimum of 48 hours off-duty.
|
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: following 48 hours off duty
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following 48 hours off duty
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ex-vivo thrombus formation using the Badimon chamber
Time Frame: following 48 hours off duty
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following 48 hours off duty
|
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Plasma t-PA and PAI concentrations following infusion of bradykinin
Time Frame: During forearm study, following 48 hours off duty
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During forearm study, following 48 hours off duty
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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 (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
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-0085
- 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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