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microRNAs in the Diagnosis of Atherosclerotic Plaque Instability

Primary Purpose

Atherosclerosis of Artery

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
blood microRNA
plaque and intima microRNA
histological examination of the plaque
blood level trimethyl N-oxide
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis of Artery focused on measuring unstable plaque, miRNA, trimethylamine N-oxide, atherosclerosis, carotid artery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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; Pregnancy. Exclusion Criteria 1. Refusal to continue participation in the study.

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University (Sechenov University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

atherosclerosis of the brachiocephalic arteries

No brachiocephalic atherosclerosis

Arm Description

The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the 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.

The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the 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). Up to 30 people - the control group without brachiocephalic atherosclerosis.

Outcomes

Primary Outcome Measures

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.
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 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.
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.
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.
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 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
January 9, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05680935
Brief Title
microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
Official Title
The Importance of Determining the Expression Level of Various microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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): In addition, all patients will take blood (20 ml) from the cubital vein to isolate microRNAs and determine the plasma content of trimethylamine N-oxide (TMAO). The resulting surgical material will be sent for histological examination and microRNA isolation. The following statistical data processing methods will be used: frequency distribution, arithmetic mean, mode, median, standard deviation, determination of normal distribution, Student's t-test, Pearson's test, Fisher's test, Spearman's correlation coefficient, multiple linear regression. During the operation according to the standard protocol of carotid endarterectomy, an atherosclerotic plaque with a small area of adjacent intima is removed. An atherosclerotic plaque obtained during a carotid endarterectomy will be sent for histological examination to determine signs of instability. The obtained data will be compared with the level of isolated microRNAs in blood and tissue (atherosclerotic plaque, intima) to detect microRNAs, which are determined during an unstable course of the atherosclerotic process. The data obtained will make it possible to predict the unstable course of atherosclerosis using non-invasive studies. This will allow timely detection of unstable plaques and help to make a decision and determine the tactics of managing patients with borderline sizes of atherosclerotic lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis of Artery
Keywords
unstable plaque, miRNA, trimethylamine N-oxide, atherosclerosis, carotid artery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
atherosclerosis of the brachiocephalic arteries
Arm Type
Experimental
Arm Description
The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the 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.
Arm Title
No brachiocephalic atherosclerosis
Arm Type
Experimental
Arm Description
The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the 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). Up to 30 people - the control group without brachiocephalic atherosclerosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood microRNA
Intervention Description
all patients will receive blood (20 ml) from the cubital vein for microRNA isolation.
Intervention Type
Diagnostic Test
Intervention Name(s)
plaque and intima microRNA
Intervention Description
The resulting surgical material will be sent for microRNA isolation.
Intervention Type
Diagnostic Test
Intervention Name(s)
histological examination of the plaque
Intervention Description
The resulting surgical material (atherosclerotic plaque) will be sent for histological examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood level trimethyl N-oxide
Intervention Description
all patients will receive blood (20 ml) from the cubital vein for determination of plasma trimethyl N-oxide (TMAO) content.
Primary Outcome Measure Information:
Title
blood microRNA
Description
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.
Time Frame
at study entry, before carotid endarterectomy.
Title
plaque microRNA
Description
- 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.
Time Frame
immediately after carotid endarterectomy
Title
blood TMAO
Description
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.
Time Frame
at study entry, before carotid endarterectomy
Title
histological examination of atherosclerotic plaque
Description
- 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.
Time Frame
immediately after carotid endarterectomy
Title
intima microRNA
Description
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.
Time Frame
immediately after carotid endarterectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Pregnancy. Exclusion Criteria 1. Refusal to continue participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Kopylov, yes
Phone
+79036877264
Email
kopylov_f_yu@staff.sechenov.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasiia Lomonosova, no
Phone
+79660583438
Email
lomonosova_a_a@staff.sechenov.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasiia Lomonosova, no
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University (Sechenov University)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp m Kopylov, yes
Phone
+79036877264
Ext
m
Email
kopylov_f_yu@staff.sechenov.ru
First Name & Middle Initial & Last Name & Degree
Anastasiia m Lomonosova, no
Phone
+79660583438
Ext
m
Email
lomonosova_a_a@staff.sechenov.ru

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not recommended by the ethical committee
Links:
URL
http://doi.org/10.18087/cardio.2019.2.10214
Description
Multislice Computed Tomography Capabilities in Assessment of the Coronary Arteries Atherosclerotic Lesions.
URL
http://elibrary.ru/item.asp?id=36370354
Description
Assessing the dynamics of vulnerability of atherosclerotic plaques in patients on atorvastatin therapy based on coronary computed tomography angiography (CCTA) data.

Learn more about this trial

microRNAs in the Diagnosis of Atherosclerotic Plaque Instability

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