- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01812317
Effect of Real-fire Training on Vascular Function (FIREPROOF)
Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. 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 the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter 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 fire-fighters professional time. Fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment.
In this study the investigators will assess healthy career fire-fighters on two occasions: following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. 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 fire suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. The investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Edinburgh, Det Forenede Kongerige, EH16 4SA
- Royal Infirmary of Edinburgh Clinical Research Facility
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Real-fire training exercise
Subjects will undergo a 20 minute standardised training exercise in a fire simulation facility.
|
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 assessment of thrombus formation using the Badimon Chamber
|
Sham-komparator: Sedentary training session
Subjects will undergo a training exercise where they will remain sedentary for 20 mins in an ambient temperature.
|
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 assessment of thrombus formation using the Badimon Chamber
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
Tidsramme: 3-6 hours post exposure
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3-6 hours post exposure
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ex-vivo thrombus formation using the Badimon chamber
Tidsramme: 2 hours post exposure
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2 hours post exposure
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Plasma t-PA and PAI concentrations following infusion of bradykinin
Tidsramme: During forearm study, 3-6 hours post exposure
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During forearm study, 3-6 hours post exposure
|
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
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 11-SS-0086
- PG/11/27/28842 (Andet bevillings-/finansieringsnummer: British Heart Foundation)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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