NCT01805063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

May 1, 2024

Status Verified

March 1, 2013

Enrollment Period

5 years

First QC Date

March 4, 2013

Last Update Submit

April 30, 2024

Conditions

Keywords

firefightersmyocardial infarctionendothelial functionthrombosisfire suppressionnon-fire emergency dutysedentary shift

Outcome Measures

Primary Outcomes (1)

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

    up to 12 hours after exposure

Secondary Outcomes (2)

  • Ex-vivo thrombus formation using the Badimon chamber

    up to 12 hours after exposure

  • Plasma t-PA and PAI concentrations following infusion of bradykinin

    During forearm study, up to 12 hours after exposure

Study Arms (3)

Fire suppression

Firefighters will attend for vascular assessments following a night shift where they have performed fire suppression

Procedure: Forearm Vascular StudyProcedure: 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.

Procedure: Forearm Vascular StudyProcedure: Badimon Chamber

Sedentary shift

Firefighters will attend for vascular assessments following a night shift where they have remained sedentary throughout the shift.

Procedure: Forearm Vascular StudyProcedure: Badimon Chamber

Interventions

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).

Also known as: BK, SNP, ACh, VP
Fire suppressionNon-fire emergency dutySedentary shift

Ex-vivo assessment of thrombus formation using the Badimon Chamber

Fire suppressionNon-fire emergency dutySedentary shift

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Non-smoking healthy firefighters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh Clinical Research Facility

Edinburgh, EH16 4SA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples

MeSH Terms

Conditions

ThrombosisMyocardial Infarction

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • David E Newby, MD PhD

    University of Edinburgh

    STUDY CHAIR
  • Nicholas L Mills, MBChB PhD

    University of Edinburgh

    STUDY DIRECTOR
  • Amanda L Hunter, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

January 9, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

May 1, 2024

Record last verified: 2013-03

Locations