- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Edinburgh, 영국, EH16 4SA
- Royal Infirmary of Edinburgh Clinical Research Facility
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Real-fire training exercise
Subjects will undergo a 20 minute standardised training exercise in a fire simulation facility.
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혈관확장제 Verapamil(10-100 µg/min), bradykinin(100-1000 pmol/min), sodium nitroprusside(2-8 µg/min) 및 아세틸콜린( 5-20µg/분).
다른 이름들:
Ex-vivo assessment of thrombus formation using the Badimon Chamber
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가짜 비교기: Sedentary training session
Subjects will undergo a training exercise where they will remain sedentary for 20 mins in an ambient temperature.
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혈관확장제 Verapamil(10-100 µg/min), bradykinin(100-1000 pmol/min), sodium nitroprusside(2-8 µg/min) 및 아세틸콜린( 5-20µg/분).
다른 이름들:
Ex-vivo assessment of thrombus formation using the Badimon Chamber
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
기간: 3-6 hours post exposure
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3-6 hours post exposure
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Ex-vivo thrombus formation using the Badimon chamber
기간: 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
기간: During forearm study, 3-6 hours post exposure
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During forearm study, 3-6 hours post exposure
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공동 작업자 및 조사자
수사관
- 연구 의자: David E Newby, MD PhD, University of Edinburgh
- 연구 책임자: Nicholas L Mills, MBChB PhD, University of Edinburgh
- 수석 연구원: Amanda L Hunter, MBChB, University of Edinburgh
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11-SS-0086
- PG/11/27/28842 (기타 보조금/기금 번호: British Heart Foundation)
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