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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01805063
Other study ID # 11-SS-0049
Secondary ID PG/11/27/28842
Status Completed
Phase
First received
Last updated
Start date January 9, 2012
Est. completion date December 31, 2016

Study information

Verified date March 2013
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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 µg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using the Badimon Chamber

Locations

Country Name City State
United Kingdom Royal Infirmary of Edinburgh Clinical Research Facility Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators up to 12 hours after exposure
Secondary Ex-vivo thrombus formation using the Badimon chamber up to 12 hours after exposure
Secondary Plasma t-PA and PAI concentrations following infusion of bradykinin During forearm study, up to 12 hours after exposure
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