The Importance of Determining the Expression Level of Various microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- blood microRNA
研究概览
简要总结
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.
详细描述
The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University). The study will include up to 50 people - the study group with atherosclerosis of the brachiocephalic arteries and up to 30 people - the control group without brachiocephalic atherosclerosis.
As part of the standard of medical care, the patient has already undergone and received the results of the following examinations before being included in the study:
- general clinical laboratory tests (complete blood count, urinalysis, low density lipoproteins, very low density lipoproteins, high density lipoproteins, total cholesterol, triglycerides, total protein, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, glucose)
- ultrasound and/or multislice computed tomography (MSCT) of brachiocephalic arteries.
Patients with clinically significant atherosclerosis of the brachiocephalic arteries were hospitalized for an operation - carotid endarterectomy with obtaining surgical material (atherosclerotic plaque with adjacent intima).
Specific methods of the planned study (procedures for examination and treatment of the patient):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability of written informed consent to participate in research work;
- •Age from 18 to 85 years;
- •Availability of data from a general blood test, blood lipid profile (total cholesterol, very low density lipoproteins, low density lipoproteins, high density lipoproteins, triglycerides);
- •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);
- •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;
- •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:
- •Chronic kidney disease stage 3b and above (glomerular filtration rate < 45 ml / min / 1.73 sq.m);
- •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;
- •Chronic somatic diseases in the acute stage;
- •Weight less than 40kg and more than 125kg;
- •Exclusion Criteria
- •Refusal to continue participation in the study.
排除标准
- 未提供
结局指标
主要结局
blood microRNA
时间窗: at study entry, before carotid endarterectomy.
* 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.
intima microRNA
时间窗: immediately after carotid endarterectomy
* 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 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.
blood TMAO
时间窗: at study entry, before carotid endarterectomy
* 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.
histological examination of atherosclerotic plaque
时间窗: immediately after carotid endarterectomy
\- 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.
plaque microRNA
时间窗: immediately after carotid endarterectomy
\- 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 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.
次要结局
未报告次要终点