Atherosclerosis of Artery Clinical Trial
Official title:
The Importance of Determining the Expression Level of Various microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
It's a non-randomized, intervention, prospective, single-center study. The aim of the work is to identify of biomarkers of unstable atherosclerosis in brachiocephalic arteries Tasks: - identify microRNAs, the expression of which is characteristic of unstable atherosclerotic lesions; - to assess the relationship of miRNA and trimethylamine N-oxide with the progression of unstable atherosclerotic lesions; - to determine the effect of the level of plasma trimethylamine N-oxide on the progression of atherosclerotic lesions.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Availability of written informed consent to participate in research work; 2. Age from 18 to 85 years; 3. Availability of data from a general blood test, blood lipid profile (total cholesterol, very low density lipoproteins, low density lipoproteins, high density lipoproteins, triglycerides); 4. Absence of clinical signs of atherosclerosis of brachiocephalic arteries (no stroke, transient ischemic attack. On auscultation of the carotid arteries, there are no additional noises); 5. Absence of signs of atherosclerosis of the brachiocephalic arteries according to ultrasound duplex scanning (USDS) and/or multispiral computed tomography (MSCT) angiography of the brachiocephalic arteries; 6. Conducted outpatient visit at a research center with clinical and biochemical blood tests performed, ultrasound examination of arterial vessels and/or multispiral tomography of arterial vessels with contrast enhancement and/or hospitalization at a research center. Non-inclusion criteria: 1. Chronic kidney disease stage 3b and above (glomerular filtration rate < 45 ml / min / 1.73 sq.m); 2. The presence of severe somatic pathology (with the exception of atherosclerosis of the carotid arteries and conditions caused by it), reducing life expectancy to less than 6 months; 3. Chronic somatic diseases in the acute stage; 4. Weight less than 40kg and more than 125kg; 5. Pregnancy. Exclusion Criteria 1. Refusal to continue participation in the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood microRNA | blood sampling from the cubital vein 20.0 ml before surgery
centrifuge ethylenediaminetetraacetic acid (EDTA) tubes with blood (ELMI centrifuge, Centrifuge model CM-6M) once at 1000 g for 10 minutes to sediment the cells; select from above ¾ of the plasma volume, so as not to capture cells, into a new empty tube; centrifuge the plasma at 2500 g for 15 minutes to sediment platelets. Remove ¾ of the supernatant without touching the pellet and transfer to a new tube. Repeat the procedure again; Aliquot the supernatant taken a second time into 1.0 ml Eppendorf tubes. Freeze (Thermo Scientific refrigerator-freezer) and store at -70°C, -80°C. |
at study entry, before carotid endarterectomy. | |
Primary | plaque microRNA | - after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy The atherosclerotic plaque obtained during the surgical intervention (carotid endarterectomy) is cut in half, the adjacent part of the intima is cut off. One half of the plaque is placed in a tube with 10% neutral buffered formalin solution and sent for histological examination. The second half and intima are placed in different test tubes with RNAprotect Tissue Reagent (Qiagen), cooled at +2 °? +4 °?, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70°?, -80°?. | immediately after carotid endarterectomy | |
Primary | blood TMAO | blood sampling from the cubital vein 20.0 ml before surgery
centrifuge the ethylenediaminetetraacetic acid (EDTA) tube with blood (ELMI centrifuge, Centrifuge model CM-6M) at 2300 g for 15 minutes; take 1.0 ml from the obtained plasma into 2 Eppendorf tubes; Freeze (Thermo Scientific refrigerator-freezer) and store at -70°C, -80°C. |
at study entry, before carotid endarterectomy | |
Primary | histological examination of atherosclerotic plaque | - after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy The atherosclerotic plaque obtained during the surgical intervention (carotid endarterectomy) is cut in half, the adjacent part of the intima is cut off. One half of the plaque is placed in a tube with 10% neutral buffered formalin solution and sent for histological examination. | immediately after carotid endarterectomy | |
Primary | intima microRNA | after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy
the intima obtained during the surgical intervention (carotid endarterectomy) is placed in a tube with RNAprotect Tissue Reagent (Qiagen), cooled at +2 °? +4 °?, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70°?, -80°?. |
immediately after carotid endarterectomy |
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