NCT01813032

Brief Summary

Emergency Service Professionals have an increased risk of death from heart attacks when compared to the general public. All the emergency professions share similar responsibilities such as emergency call-outs and shift work. Heart disease is the commonest cause of on-duty death amongst fire-fighters accounting for 45% and compared with 22% in police officers and 15% in the general population. 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 this study the investigators will assess healthy career fire-fighters and age-matched healthy police officer control subjects following a sedentary period. 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 how the blood vessels respond following these duties. The investigators hypothesise that fire-fighters do not have pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of their occupation, but rather these are acute and transitory effects following distinct fire-fighter duties. We therefore expect similar results in both occupational groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 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

April 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 3, 2024

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

March 14, 2013

Last Update Submit

May 2, 2024

Conditions

Keywords

firefighterspolice officersemergency service professionalsmyocardial infarctionendothelial functionthrombosis

Outcome Measures

Primary Outcomes (1)

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

    following 48 hours off duty

Secondary Outcomes (2)

  • Ex-vivo thrombus formation using the Badimon chamber

    following 48 hours off duty

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

    During forearm study, following 48 hours off duty

Study Arms (2)

Firefighters

20 firefighters will attend for vascular assessments following a minimum of 48 hours off-duty.

Procedure: Forearm Vascular StudyProcedure: Badimon Chamber

Police Officers

20 police officers will attend for vascular assessments following a minimum of 48 hours off-duty.

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
FirefightersPolice Officers

Ex-vivo assessment of thrombus formation using the Badimon Chamber

FirefightersPolice Officers

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
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 and age- and sex-matched police officers who are also healthy and non-smokers working within Lothian and Borders Police Force.

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.

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 CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 18, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 3, 2024

Record last verified: 2013-03

Locations