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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01813032
Other study ID # 11-SS-0085
Secondary ID PG/11/27/28842
Status Completed
Phase
First received
Last updated
Start date April 2012
Est. completion date April 2013

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

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
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 following 48 hours off duty
Secondary Ex-vivo thrombus formation using the Badimon chamber following 48 hours off duty
Secondary Plasma t-PA and PAI concentrations following infusion of bradykinin During forearm study, following 48 hours off duty
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