Cardiovascular Risk Factor, C.Medical Procedure; Vascular, Functional or Late, Electrolyte and Fluid Balance Conditions
Conditions
Keywords
Vascular function, Inflammation, Oxidative stress, Hemostatic balance, Aspirin, Firefighting
Brief summary
The investigators hypothesize that 1. 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. 2. 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. 3. 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.
Interventions
DRUG81 mg enteric coated aspirin
81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting
Sponsors
Federal Emergency Management Agency
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular function | Less than 60 minutes before initiating 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. |
| Hemostatic balance | Less than 60 minutes before initiating 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 |
| Inflammatory and Oxidative Stress markers | Less than 60 minutes before initiating firefighting activity | CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin |
Countries
United States
Outcome results
None listed