NCT03855891

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

February 25, 2019

Last Update Submit

December 19, 2020

Conditions

Keywords

Ischemic Heart DiseaseAtherosclerosismicro-RNAmultislice spiral computed tomographycoronary angiography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study group

EXPERIMENTAL

A group of patients with blood tests

Diagnostic Test: blood test

Interventions

blood testDIAGNOSTIC_TEST

Blood test for spectrum and level of cardiospecific micro-RNA

Study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMSechenovMMA

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Myocardial IschemiaAtherosclerosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Philipp Kopylov, Professor

    Sechenov Univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-graduate student of Department of of Preventive and Emergency Cardiology I.M. Sechenov First Moscow State Medical University

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

January 1, 2019

Primary Completion

August 14, 2020

Study Completion

October 1, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.

Locations