Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA

NCT ID: NCT03855891

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-10-01

Brief Summary

The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT).

Detailed Description

The study will be conducted in two phases. Phase one. After signing the informed consent, patients with coronary heart disease, angina pectoris II-IV functional class, who underwent MSCT angiography of the coronary arteries for medical reasons, regulated in the relevant ESC and the Russian Society of Cardiology guidelines, will be included in the study. According to the results of MSCT, the participants will be divided into 4 groups: those with atherosclerotic plaques with signs of instability; those with stable atherosclerotic plaques without marked calcification; those with calcined atherosclerotic plaques; those with no signs of atherosclerosis of the coronary arteries. Plasma samples will be analyzed by microarray, using a cardiospecific set.

Phase two. Validation of the results obtained after the first phase will be performed on a larger sample of patients. Patients after signing an informed consent will also undergo MSCT angiography of coronary arteries and according to its results will be devided in 4 groups. To assess the level of microRNA expression in the blood of patients, real-time reverse transcription-polymerase chain reaction (RT-PCR) will be used.

The expected result of the study. For the first time ever, there will be determined the profile of circulating regulatory RNA in patients who underwent MSCT angiography of coronary arteries. Features of expression of circulating microRNAs will be compared with different severity degrees of the atherosclerotic process based on MSCT criteria. The results will be compared with each other (including the "control" group), which will allow to identify common patterns and specific differences.

Conditions

Ischemic Heart Disease; Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

A group of patients with blood tests

Group Type: EXPERIMENTAL

blood test

Intervention Type: DIAGNOSTIC_TEST

Blood test for spectrum and level of cardiospecific micro-RNA

Interventions

blood test

Blood test for spectrum and level of cardiospecific micro-RNA

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Written informed consent of the patient to participate in the study;
• Age 18-80;
• The presence of medical indications for MSCT angiography of coronary arteries in connection with suspected coronary heart disease.

Exclusion Criteria

• Age less than 18 or more than 80;
• Pregnancy, breast-feeding;
• Patients who have not undergone (and do not plan) MSCT coronary angiography;
• Any surgical intervention on the heart in history;
• Severe heart failure (III-IV NYHA classes);
• History of myocardial infarction;
• The body mass index of 35 or more;
• More than twice the ALT and/or AST level;
• The presence of severe somatic pathology (except coronary atherosclerosis);
• Patient's refusal to participate in the study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Andrei N Rozhkov, MD

Post-graduate student of Department of of Preventive and Emergency Cardiology I.M. Sechenov First Moscow State Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philipp Kopylov, Professor

Role: PRINCIPAL_INVESTIGATOR

Sechenov Univercity

Locations

IMSechenovMMA

Moscow, , Russia

Countries

Russia

Other Identifiers

1741909-2019

Identifier Type: -

Identifier Source: org_study_id