Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Inflammatory and Oxidative Stress markers
研究概览
简要总结
The investigators hypothesize that
- an acute treatment of low-dose aspirin will lead to a) decreased resting platelet activation, platelet aggregation, and clotting potential, b) increased fibrinolytic potential following fire fighting, c) no significant effect on endothelial function or arterial stiffness versus the placebo condition.
- chronic treatment with low-dose aspirin will lead to a) decreased resting and fire fighting induced platelet activation, platelet aggregation, clotting potential, b) increased fibrinolytic potential, and c) increased endothelial function and decreased arterial stiffness in response to live fire fighting versus the placebo condition.
- short-term fire fighting activity will result in: a) a reduction in arterial function (reduced endothelial function, increased augmentation index and an attenuated arterial stiffness response); b) a disruption in hemostasis that is characterized by an increase in platelet number and function, an increased coagulatory potential and altered fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic inflammation, monokine chemoattractant protein, and matrix metalloproteinases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male firefighters (career and volunteer), medically cleared by home fire department.
- •Ages 40 - 60
- •Completion of a yearly period medical evaluation based on NFPA 1582 within the past 12 months or an evaluation by an occupational medical group through this study.
排除标准
- •Over 60 or under 40 years of age.
- •Not a firefighter.
- •Individuals at risk for developing gastrointestinal (GI) complications while on aspirin therapy due to a combination of the following: smoking; concurrent NSAID, steroid, Clopidogrel, or Warfarin therapy; history of upper GI complications; history of renal impairment; history of elevated serum creatinine; hypertension; and cardiac failure.
- •Individuals with cases of allergy or asthma, intolerance, and recurrent vascular events.
- •Individuals taking statins.
- •Individuals who are currently taking aspiring regularly.
研究组 & 干预措施
Chronic, Aspirin
81 mg asprin provided prior to firefighting- 14 day dosage
干预措施: 81 mg enteric coated aspirin (Drug)
Acute, Aspirin
81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage
干预措施: 81 mg enteric coated aspirin (Drug)
Acute, Placebo
Acute single dosage of placebo provided 30 minutes prior to firefighting
干预措施: 81 mg enteric coated aspirin (Drug)
Chronic, Placebo
14 day dosage of placebo provided prior to firefighting
干预措施: 81 mg enteric coated aspirin (Drug)
结局指标
主要结局
Inflammatory and Oxidative Stress markers
时间窗: Less than 60 minutes after completing 20 minutes of firefighting activity
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
Hemostatic balance
时间窗: Less than 60 minutes after completing 20 minutes of firefighting activity
Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Vascular function
时间窗: Less than 60 minutes after completing 20 minutes of firefighting activity
Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.
次要结局
未报告次要终点
研究者
Gavin Horn
Senior Research Scientist
University of Illinois at Urbana-Champaign