microRNAs in the Diagnosis of Atherosclerotic Plaque Instability (NCT05680935) | Clinical Trial Compass
CompletedNot Applicable
microRNAs in the Diagnosis of Atherosclerotic Plaque Instability
Russia90 participantsStarted 2022-09-05
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
blood microRNA
Timeframe: at study entry, before carotid endarterectomy.
2
plaque microRNA
Timeframe: immediately after carotid endarterectomy
3
blood TMAO
Timeframe: at study entry, before carotid endarterectomy
4
histological examination of atherosclerotic plaque
Timeframe: immediately after carotid endarterectomy
5
intima microRNA
Timeframe: immediately after carotid endarterectomy
Trial details
NCT IDNCT05680935
SponsorI.M. Sechenov First Moscow State Medical University
. 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;