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Effect of Fire Suppression and Emergency Duties on Vascular Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Edinburgh
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01805063
First received: March 4, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted

March 4, 2013
March 4, 2013
February 2012
August 2014   (final data collection date for primary outcome measure)
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators [ Time Frame: up to 12 hours after exposure ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Ex-vivo thrombus formation using the Badimon chamber [ Time Frame: up to 12 hours after exposure ] [ Designated as safety issue: No ]
  • Plasma t-PA and PAI concentrations following infusion of bradykinin [ Time Frame: During forearm study, up to 12 hours after exposure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Fire Suppression and Emergency Duties on Vascular Function
Effect of Fire Suppression and Emergency Duties on Vascular Function in Firefighters

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.

Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma and urine samples

Probability Sample

Subjects will be healthy, non-smoking, whole-time firefighters working within Lothian and Borders Fire and Rescue Service

  • Vascular Function
  • Atherothrombosis
  • 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
    Ex-vivo assessment of thrombus formation using the Badimon Chamber
  • Fire suppression
    Firefighters will attend for vascular assessments following a night shift where they have performed fire suppression
    Interventions:
    • Procedure: Forearm Vascular Study
    • Procedure: Badimon Chamber
  • Non-fire emergency duty
    Firefighters will attend for vascular assessments following a night shift where they have had an emergency response without fire suppression eg. road traffic collision.
    Interventions:
    • Procedure: Forearm Vascular Study
    • Procedure: Badimon Chamber
  • Sedentary shift
    Firefighters will attend for vascular assessments following a night shift where they have remained sedentary throughout the shift.
    Interventions:
    • Procedure: Forearm Vascular Study
    • Procedure: Badimon Chamber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Amanda L Hunter, MBChB +441312426437 amanda.hunter@ed.ac.uk
Contact: Nicholas L Mills, MBChB PhD +441312426437 nick.mills@ed.ac.uk
United Kingdom
 
NCT01805063
11-SS-0049, PG/11/27/28842
Yes
University of Edinburgh
University of Edinburgh
Not Provided
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
University of Edinburgh
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP