Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT05680935
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):
1. 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.
2. 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:
NCT05680935
Study Brief:
Protocol Section:
NCT05680935