Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA (CT-CA-miRNA)

Evaluation of the Circulating Micro-RNA Profile Specificity in Patients With Different Stages of Atherosclerosis According to MSCT Coronary Angiography

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).

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Ischemic Heart Disease
• Intervention / Treatment: Diagnostic test: blood test

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • IMSechenovMMA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; A group of patients with blood tests	Diagnostic test: blood test; Blood test for spectrum and level of cardiospecific micro-RNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the profile of circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.	Analysis of the spectrum and levels of cardiospecific circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.	2 days

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Philipp Kopylov, Professor, Sechenov Univercity

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 14, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Atherosclerosis; Ischemic Heart Disease; coronary angiography; micro-RNA; multislice spiral computed tomography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 1741909-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No