Apoptosis Proteins and Endothelial Dysfunction in Patients With Atherosclerosis of Peripheral Arteries
NCT ID: NCT04502849
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2020-01-01
2023-11-01
Brief Summary
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At present, the apoptosis system plays an equally important role in the development of restenosis of the intervention zone. It has been recognized as a central component in the pathogenesis of atherosclerosis, in which the Bcl-2 family of proteins is activated. It is a group of cellular proteins that are important regulators of the apoptosis system in cells located in the mitochondrial membrane. In experimental animal models, it was shown that apoptosis after angioplasty of the coronary arteries proceeds in the form of two waves. After injury to the vascular wall, during the first hours, it is activated in the smooth muscle cells (SMC) of media, and after two weeks in the cells of the neointima, by the 28th day it almost completely stops. A decrease in the apoptosis index in the postoperative period may cause the development of restenosis of the reconstruction zone. The use of antioxidants, for example, alpha-tocopherol acetate, in the first month of the postoperative period, at the time of activation of apoptosis, inhibits the latter and reduces the proliferative activity of the SMC media and neointima. One month after surgery, delayed apoptosis of vascular wall cells can lead to the development of neointima and restenosis. In this case, the use of drugs that enhance apoptosis, for example, lipophilic statins, calcium channel blockers, will be relevant.
Nitric oxide metabolites, depending on the concentration, can act as both an inducer and an inhibitor of apoptosis. The mechanism of NO-induced apoptosis in SMC includes an increase in the Bax / Bcl-2 expression ratio, which leads to the release of cytochrome C from mitochondria, activation of caspase-3 and -9. In patients with atherosclerosis of the peripheral arteries, proteins of the Bcl-2 family and their relationship with markers of endothelial dysfunction have not been sufficiently studied, the results obtained are contradictory.
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Detailed Description
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Arterial wall sampling for apoptosis and proliferation (Bcl-2, Bax, Fas, p53, PDGF-BB, VEGF) during surgery in group A-C patients.
Duplex ultrasound of lower limbs arteries will be performed before,1, 6, 12, 18 and 24 month after surgery for groups A-D and for group E when included into study.
100 mg per os of Vitamin E 1 per day during 1 month after surgery will be prescribed to half of groups A-C patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group "Bypass" (A)
50 patients with indications for bypass surgery (chronic lower limb ischemia, stage 2b-4 Fontaine).
Bypass surgery
Creating a bypass with graft or vein.
Vitamin E
100 mg Vitamin E per os 1 per day (1 month).
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Arterial wall sampling
Arterial wall sampling for apoptosis markers.
Group "Endovascular" (B)
50 patients with indications for endovascular angioplasty and stenting (chronic lower limb ischemia, stage 2b-4 Fontaine).
Endovascular angioplasty/stenting
Performing an angioplasty with or without stenting in stenosis.
Vitamin E
100 mg Vitamin E per os 1 per day (1 month).
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Group "Hybrid" (C)
50 patients with indications for hybrid surgery (endovascular angioplasty/stenting and bypass surgery; chronic lower limb ischemia, stage 2b-4 Fontaine).
Hybrid surgery
Performing an angioplasty with or without stenting in stenosis and creating a bypass with graft or vein.
Vitamin E
100 mg Vitamin E per os 1 per day (1 month).
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Arterial wall sampling
Arterial wall sampling for apoptosis markers.
Group "Conservative" (D)
50 patients without indications surgery (conservative treatment, chronic lower limb ischemia, stage 2b-4 Fontaine).
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Group "Healthy volunteers" (E)
50 healthy subjects.
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Interventions
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Bypass surgery
Creating a bypass with graft or vein.
Endovascular angioplasty/stenting
Performing an angioplasty with or without stenting in stenosis.
Hybrid surgery
Performing an angioplasty with or without stenting in stenosis and creating a bypass with graft or vein.
Vitamin E
100 mg Vitamin E per os 1 per day (1 month).
Duplex ultrasound
Duplex ultrasound of lower limbs arteries.
Blood sampling
Blood sampling for apoptosis and endothelial dysfunction markers.
Arterial wall sampling
Arterial wall sampling for apoptosis markers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presence of atherosclerotic peripheral artery disease.
Exclusion Criteria
* chronic lower limb ischemia of a different etiology (disease Burger, aortoarteritis, etc.),
* active cancer or remission period less than 5 years;
* decompensated diabetes mellitus;
* pregnancy or breastfeeding in women
40 Years
ALL
Yes
Sponsors
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Ryazan State Medical University
OTHER
Responsible Party
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Principal Investigators
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Igor A Suchkov, Sc.D.
Role: PRINCIPAL_INVESTIGATOR
Ryazan State Medical University
Locations
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Ryazan State Medical University
Ryazan, , Russia
Countries
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Other Identifiers
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25.07
Identifier Type: -
Identifier Source: org_study_id
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