Atherosclerosis of ArteryNCT05680935
microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
A study testing blood microRNA, plaque and intima microRNA and histological examination of the plaque in people with Atherosclerosis of Artery, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis of Artery
- What is being tested?
- blood microRNA, plaque and intima microRNA and histological examination of the plaque
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteRussia
- Study dates
- 5 Sep 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 1. Refusal to continue participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119991
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis of Artery
- Being tested
- blood microRNA, plaque and intima microRNA, histological examination of the plaque, blood level trimethyl N-oxide
- Keywords
- unstable plaque, miRNA, trimethylamine N-oxide, atherosclerosis, carotid artery
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood microRNADiagnostic test
all patients will receive blood (20 ml) from the cubital vein for microRNA isolation.
plaque and intima microRNADiagnostic test
The resulting surgical material will be sent for microRNA isolation.
histological examination of the plaqueDiagnostic test
The resulting surgical material (atherosclerotic plaque) will be sent for histological examination.
blood level trimethyl N-oxideDiagnostic test
all patients will receive blood (20 ml) from the cubital vein for determination of plasma trimethyl N-oxide (TMAO) content.
| Study group | Role | What they receive |
|---|---|---|
| atherosclerosis of the brachiocephalic arteries | Experimental | 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. Receives: Diagnostic Test: blood microRNA; Diagnostic Test: plaque and intima microRNA; Diagnostic Test: histological examination of the plaque; Diagnostic Test: blood level trimethyl N-oxide |
| No brachiocephalic atherosclerosis | Experimental | 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. Receives: Diagnostic Test: blood microRNA; Diagnostic Test: blood level trimethyl N-oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at study entry, before carotid endarterectomy.
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.
Measured: immediately after carotid endarterectomy
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.
Measured: at study entry, before carotid endarterectomy
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.
Measured: immediately after carotid endarterectomy
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.
Measured: immediately after carotid endarterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start5 Sep 2022
- Primary completion28 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasiia Lomonosova, no, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680935
- Sponsor's protocol ID
- 132578
- Status last verified
- Mar 2024
- First submitted
- 21 Dec 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not recommended by the ethical committee
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Determining the Expression Level of Various microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
- ClinicalTrials.gov ID
- NCT05680935
- Acronym / sponsor ID
- 132578
- Conditions
- Atherosclerosis of Artery
- Keywords
- unstable plaque, miRNA, trimethylamine N-oxide, atherosclerosis, carotid artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atherosclerosis of the brachiocephalic arteries | Experimental | Diagnostic Test: blood microRNA, Diagnostic Test: plaque and intima microRNA, Diagnostic Test: histological examination of the plaque, Diagnostic Test: blood level trimethyl N-oxideThe 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. |
| No brachiocephalic atherosclerosis | Experimental | Diagnostic Test: blood microRNA, Diagnostic Test: blood level trimethyl N-oxideThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (1 listed)
- 1. Refusal to continue participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood microRNAall patients will receive blood (20 ml) from the cubital vein for microRNA isolation. | Diagnostic test | No brachiocephalic atherosclerosis, atherosclerosis of the brachiocephalic arteries |
| plaque and intima microRNAThe resulting surgical material will be sent for microRNA isolation. | Diagnostic test | atherosclerosis of the brachiocephalic arteries |
| histological examination of the plaqueThe resulting surgical material (atherosclerotic plaque) will be sent for histological examination. | Diagnostic test | atherosclerosis of the brachiocephalic arteries |
| blood level trimethyl N-oxideall patients will receive blood (20 ml) from the cubital vein for determination of plasma trimethyl N-oxide (TMAO) content. | Diagnostic test | No brachiocephalic atherosclerosis, atherosclerosis of the brachiocephalic arteries |
Primary outcome
blood microRNA
Time frame: 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.
plaque microRNA
Time frame: 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.
blood TMAO
Time frame: 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
Time frame: 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.
intima microRNA
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Multislice Computed Tomography Capabilities in Assessment of the Coronary Arteries Atherosclerotic Lesions.Link provided by the sponsor.
- Individual participant dataSharing planned: No. not recommended by the ethical committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasiia Lomonosova, no principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood microRNA, plaque and intima microRNA and histological examination of the plaque in people with Atherosclerosis of Artery, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood microRNA (time frame: at study entry, before carotid endarterectomy.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.