Overview
The study is aimed at assessing the role of the activity of markers of endothelial dysfunction (cytotoxic malonic aldehyde (MDA), angiotensin II, endothelial nitric oxide synthase (NO), endothelin-1, prostacyclin) in the systemic circulation in patients with lower extremity atherosclerotic arterial occlusive disease undergoing open reconstructive interventions.
Description
The study will include 120 patients of similar age, gender, and ethnicity, they will be divided into four groups: Group I: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy; Group II: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage IIA-IIB of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®; Group III: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stageIII-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee); Group IV: 30 patients with lower extremity atherosclerotic arterial occlusive disease, stage III-IV of the disease according to the Fontaine-Pokrovsky classification, receiving conservative therapy, including the drug based on vascular polypeptides Slavinorm®, in combination with surgical methods of treatment (femoral-popliteal bypass grafting with a synthetic graft above the knee).
Eligibility
Inclusion Criteria:
men or women over 18 years of age with lower extremity atherosclerotic arterial occlusive
disease, confirmed with instrumental work-up methods (ultrasonography or angiography).
Exclusion Criteria:
men or women under 18 years of age; history of anaphylaxis; hypersensitivity to any of the
components that make up the drug Slavinorm®, and proteins of animal origin; absolute and
relative contraindications to the treadmill test; failure to walk at a minimum speed of 3.2
km/h (2 mph) at a minimum treadmill angle for at least 2 minutes during the stress test
during the screening phase; depression of the ST segment more than 1 mm in one or more
standard leads on the electrocardiogram; peripheral artery disease not associated with
atherosclerosis; patients who underwent reconstructive surgery or invasive interventions on
the arteries of the lower extremities in history without a clinic of intermittent
claudication; angina pectoris III-IV functional class (FC) according to the CCS
classification; body mass index >35 kg/m2; acute or chronic renal (creatinine clearance
less than 30 ml / min) and / or liver failure [aspartate aminotransferase (AST), alanine
aminotransferase (ALT) > 3 times the upper limit of normal]; chronic heart failure III-IV
FC according to NYHA; acute coronary syndrome within 6 months. before the start of the
screening period; any clinically significant condition or comorbidity that, in the opinion
of the Investigator, would preclude the patient from participating in the study.