Trial record 5 of 35 for:    Open Studies | "Emergency Medical Services"

Comparison of Vascular Function in Emergency Service Professionals (FIRECOP)

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:
NCT01813032
First received: March 14, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Vascular Function
Atherothrombosis
Procedure: Forearm Vascular Study
Procedure: Badimon Chamber

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Vascular Function in Emergency Service Professionals

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators [ Time Frame: following 48 hours off duty ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ex-vivo thrombus formation using the Badimon chamber [ Time Frame: following 48 hours off duty ] [ Designated as safety issue: No ]
  • Plasma t-PA and PAI concentrations following infusion of bradykinin [ Time Frame: During forearm study, following 48 hours off duty ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and urine.


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Firefighters
20 firefighters will attend for vascular assessments following a minimum of 48 hours off-duty.
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
Police Officers
20 police officers will attend for vascular assessments following a minimum of 48 hours off-duty.
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813032

Contacts
Contact: Amanda L Hunter, MBChB +441312426437 amanda.hunter@ed.ac.uk
Contact: Nicholas L Mills, MBChB PhD +441312426437 nick.mills@ed.ac.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Clinical Research Facility Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Amanda L Hunter, MBChB    +441312426437    amanda.hunter@ed.ac.uk   
Contact: Nicholas L Mills, MBChB PhD    +441312426437    nick.mills@ed.ac.uk   
Principal Investigator: Amanda L Hunter, MBChB         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01813032     History of Changes
Other Study ID Numbers: 11-SS-0085, PG/11/27/28842
Study First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Edinburgh:
firefighters
police officers
emergency service professionals
myocardial infarction
endothelial function
thrombosis

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014