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

Primary Purpose

Ischemic Heart Disease, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
blood test
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Heart Disease focused on measuring Ischemic Heart Disease, Atherosclerosis, micro-RNA, multislice spiral computed tomography, coronary angiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • IMSechenovMMA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

A group of patients with blood tests

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2019
Last Updated
December 19, 2020
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03855891
Brief Title
Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA
Acronym
CT-CA-miRNA
Official Title
Evaluation of the Circulating Micro-RNA Profile Specificity in Patients With Different Stages of Atherosclerosis According to MSCT Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Atherosclerosis
Keywords
Ischemic Heart Disease, Atherosclerosis, micro-RNA, multislice spiral computed tomography, coronary angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
A group of patients with blood tests
Intervention Type
Diagnostic Test
Intervention Name(s)
blood test
Intervention Description
Blood test for spectrum and level of cardiospecific micro-RNA
Primary Outcome Measure Information:
Title
Determination of the profile of circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Kopylov, Professor
Organizational Affiliation
Sechenov Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMSechenovMMA
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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