Clinical Trials Logo

Clinical Trial Summary

Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.


Clinical Trial Description

Each patient will be examined 4 times: Visit 1 (day -1) - collecting and documenting patients' complaints and medical history - local examination - ultrasound angiography of the lower limbs veins - assessment of clinical grade according to CEAP classification Visit 2 (day 0) - assessment of venous disease severity according to Venous Clinical Severity Score (VCSS) - assessment of quality of life with Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) - assessment of clinical grade according to CEAP classification - measurement of microcirculation in the operated limb by laser flowmetry using portable device (laser Doppler flowmetry (LDF) registration will be performed on leg anterior surface (lower third) for 10 minutes) - assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, plasminogen activator inhibitor-1 (PAI-1), E-selectin, P-selectin, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular endothelial cell adhesion molecule-1 (sVCAM-1) - flow cytometry analysis of circulating cells expressing surface markers (clusters of differentiation (CD)): CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+ - surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol - patients' randomization (method of random numbers) into 2 treatment groups of 20 subjects each with sulodexide treatment (250 LSU bid for 30 day) for the active treatment group and without any additional pharmacotherapy for the control group Visit 3 (day 4 after intervention) - ultrasound angiography of the operated limb (evaluation of the venous ablation and examination of endothermal heat-induced thrombosis (EHIT)) Visit 4 (day 32 after intervention) - collecting and documenting patients' complaints - local examination - ultrasound angiography of the lower limbs veins - assessment of clinical grade according to CEAP classification - assessment of venous disease severity according to VCSS - assessment of quality of life with CIVIQ-20 - measurement of microcirculation in the operated limb by laser flowmetry using portable device - assesment of blood laboratory parameters of endothelial dysfunction: homocysteine, von Willebrand factor, PAI-1, E-selectin, P-selectin, sICAM-1, sVCAM-1 - flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+ ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04180137
Study type Interventional
Source State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Contact
Status Completed
Phase N/A
Start date November 28, 2019
Completion date July 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT04156711 - Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery N/A
Recruiting NCT06133634 - Fisetin to Improve Vascular Function in Older Adults Phase 1/Phase 2
Completed NCT05872139 - Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging N/A
Recruiting NCT04558450 - Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN) N/A
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Recruiting NCT02334839 - The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction N/A
Recruiting NCT02020044 - Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) N/A
Completed NCT01691404 - Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO) N/A
Completed NCT01775865 - Targeting Inflammation to Treat Cardiovascular Aging Phase 2
Terminated NCT01412216 - The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance Phase 2
Completed NCT01319344 - Effect of Eplerenone on Endothelial Function in Metabolic Syndrome Phase 3
Completed NCT00848302 - Endothelial Function in Human Arteries Early Phase 1
Completed NCT00990730 - Atherosclerosis in Rheumatoid Arthritis N/A
Completed NCT00987974 - Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury Phase 4
Completed NCT00532844 - A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction Phase 2
Completed NCT00376246 - Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects Phase 4
Completed NCT00775099 - Combustion Derived Air Pollution and Vascular Function N/A