- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01813032
Comparison of Vascular Function in Emergency Service Professionals (FIRECOP)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Amanda L Hunter, MBChB
- Telefonnummer: +441312426437
- E-mail: amanda.hunter@ed.ac.uk
Undersøgelse Kontakt Backup
- Navn: Nicholas L Mills, MBChB PhD
- Telefonnummer: +441312426437
- E-mail: nick.mills@ed.ac.uk
Studiesteder
-
-
-
Edinburgh, Det Forenede Kongerige, EH16 4SA
- Rekruttering
- Royal Infirmary of Edinburgh Clinical Research Facility
-
Kontakt:
- Amanda L Hunter, MBChB
- Telefonnummer: +441312426437
- E-mail: amanda.hunter@ed.ac.uk
-
Kontakt:
- Nicholas L Mills, MBChB PhD
- Telefonnummer: +441312426437
- E-mail: nick.mills@ed.ac.uk
-
Ledende efterforsker:
- Amanda L Hunter, MBChB
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Firefighters
20 firefighters will attend for vascular assessments following a minimum of 48 hours off-duty.
|
Underarm venøs okklusion plethysmografi til måling af underarmens blodgennemstrømning under intraarteriel infusion af vasodilatorerne Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), natriumnitroprussid (2-8 µg/min) og acetylcholin ( 5-20 µg/min).
Andre navne:
Ex-vivo vurdering af trombedannelse ved brug af Badimon-kammeret
|
Police Officers
20 police officers will attend for vascular assessments following a minimum of 48 hours off-duty.
|
Underarm venøs okklusion plethysmografi til måling af underarmens blodgennemstrømning under intraarteriel infusion af vasodilatorerne Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), natriumnitroprussid (2-8 µg/min) og acetylcholin ( 5-20 µg/min).
Andre navne:
Ex-vivo vurdering af trombedannelse ved brug af Badimon-kammeret
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
Tidsramme: following 48 hours off duty
|
following 48 hours off duty
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ex-vivo thrombus formation using the Badimon chamber
Tidsramme: following 48 hours off duty
|
following 48 hours off duty
|
Plasma t-PA and PAI concentrations following infusion of bradykinin
Tidsramme: During forearm study, following 48 hours off duty
|
During forearm study, following 48 hours off duty
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: David E Newby, MD PhD, University of Edinburgh
- Studieleder: Nicholas L Mills, MBChB PhD, University of Edinburgh
- Ledende efterforsker: Amanda L Hunter, MBChB, University of Edinburgh
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-SS-0085
- PG/11/27/28842 (Andet bevillings-/finansieringsnummer: British Heart Foundation)
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