Peripheral Arterial Disease Clinical Trial
Official title:
The Assessment of Cysteinyl Leukotriene Receptor Antagonist Role in Inhibition of Atherosclerosis, Proliferation and Its Influence on Endothelial Function in Patients Undergoing Endovascular Treatment Due to Peripheral Arterial Disease.
Atherosclerosis is a civilization disease, which pathophysiology is based on chronic
inflammatory response in the wall of vessels that is caused by increase of pro-inflammatory
substances. It is a significant challenge for diagnostics and pharmacology. This disease
occurs in over 60% of the population over 70 years old. There are many factors that are
responsible for this process including group of the arachidonic acid metabolism products -
leukotriens, especially leukotriene E4 (LTE4). The effect of these factors was described as
the base of pathology not only cardiovascular diseases but also the base of development of
asthma and other allergic diseases. The substance which blocks the activity of these factors
- montelukast - is a common method of treatment in asthma.
The aim of this project is to investigate the influence of cysteinyl leukotriens receptor
antagonists on lower limb arteries reocclusion rate in patients with peripheral artery
disease (PAD) after endovascular treatment.
During previous years we conducted a prospective study, which helped us evaluating the
dynamics of leukotriens and thromboxane levels in patients with PAD, who underwent
endovascular treatment - peripheral transluminal angioplasty (PTA). We established for the
first time the dependence between the increased level of LTE4 in urine (uLTE4) and restenosis
or reocclusion occurrence, which translates to the necessity of further procedures and a
decrease in the quality of life. We should ask ourselves a question: Is blocking of cysteinyl
leukotriens reaction as proinflammatory and proliferative factors, by the use of receptor
CysLT1 antagonists going to decrease the quantity of restenosis and reocclusions after
endovascular treatment? Within the project performed in the Angiology Department of
Jagiellonian University among the patients suffering from PAD and fulfilling all inclusion
criteria, the randomized double-blinded clinical study will be performed. Patients will be
assigned to two groups: Treatment Group (which will be receiving cysteinyl leukotriene
antagonist (montelukast) in a dose of 10mg/day for 12 months) and Control Group to which
placebo will be administered. Among all patients population, at every visit at 1., 3., 6.,
and 12-month clinical state, ultrasound, hemodynamic parameters, and endothelium imaging will
be performed as well as uLTE4 measurements. A comparison of the results between both groups
will give us an answer if blocking uLTE4 receptors may become a breakthrough in future
atherosclerosis treatment.
The mechanisms, which lead to restenosis is still not fully understood, and currently used
methods of treatment - antiplatelets, anti-proliferative drugs, and anticoagulants - are not
fully effective. Thanks to this research the knowledge about treatment and prevention of
atherosclerosis will be increased, which will be connected with future better patient care,
especially patients with PAD.
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