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Completed

NCT Number: NCT01812317

Effect of Real-fire Training on Vascular Function

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh Clinical Research Facility

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm Vascular Study

Procedure

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: BK, SNP, ACh, VP

Badimon Chamber Study

Procedure

Ex-vivo assessment of thrombus formation using the Badimon Chamber

Primary outcomes

  1. Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators

    Time frame: 3-6 hours post exposure

Secondary outcomes

  1. Ex-vivo thrombus formation using the Badimon chamber

    Time frame: 2 hours post exposure

  2. Plasma t-PA and PAI concentrations following infusion of bradykinin

    Time frame: During forearm study, 3-6 hours post exposure

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Acronym: FIREPROOF

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2013
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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