Effect of Real-fire Training on Vascular Function (FIREPROOF)

June 17, 2021 updated by: University of Edinburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real-fire training exercise
Subjects will undergo a 20 minute standardised training exercise in a fire simulation facility.
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).
Other Names:
  • BK
  • SNP
  • ACh
  • VP
Procedure: Badimon Chamber Study
Ex-vivo assessment of thrombus formation using the Badimon Chamber
Sham Comparator: Sedentary training session
Subjects will undergo a training exercise where they will remain sedentary for 20 mins in an ambient temperature.
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).
Other Names:
  • BK
  • SNP
  • ACh
  • VP
Procedure: Badimon Chamber Study
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: 3-6 hours post exposure
3-6 hours post exposure

Secondary Outcome Measures

Outcome Measure
Time Frame
Ex-vivo thrombus formation using the Badimon chamber
Time Frame: 2 hours post exposure
2 hours post exposure
Plasma t-PA and PAI concentrations following infusion of bradykinin
Time Frame: During forearm study, 3-6 hours post exposure
During forearm study, 3-6 hours post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-SS-0086
  • 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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