Effect of Real-fire Training on Vascular Function

Vascular Function Clinical Trial

— FIREPROOF  

Official title:

Effect of Real-fire Training on Vascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812317
• Other study ID #: 11-SS-0086
• Secondary ID: PG/11/27/28842
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: September 2016

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. 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 the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter 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 fire-fighters professional time. Fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment.

In this study the investigators will assess healthy career fire-fighters on two occasions:

following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. 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 fire suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. The investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2016
• Est. primary completion date: September 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

Related Conditions & MeSH terms

• Atherothrombosis
• Vascular Function

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 Study
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, 

References & Publications (1)

Hunter AL, Shah AS, Langrish JP, Raftis JB, Lucking AJ, Brittan M, Venkatasubramanian S, Stables CL, Stelzle D, Marshall J, Graveling R, Flapan AD, Newby DE, Mills NL. Fire Simulation and Cardiovascular Health in Firefighters. Circulation. 2017 Apr 4;135( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators		3-6 hours post exposure
Secondary	Ex-vivo thrombus formation using the Badimon chamber		2 hours post exposure
Secondary	Plasma t-PA and PAI concentrations following infusion of bradykinin		During forearm study, 3-6 hours post exposure