Genetics of Cardiovascular Disease

Last updated: February 2, 2024
Sponsor: Center for Strategic Planning, of the Federal Medical and Biological Agency
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Coronary Artery Disease

Angina

Treatment

N/A

Clinical Study ID

NCT06253481
Cardiogen
  • Ages > 18
  • All Genders

Study Summary

Participants are being recruited at the inpatient department of the National Medical Research Center of Cardiology on a 'all-comers' basis. The enrolled participants will be divided into the main group (diagnosed with atherosclerotic cardiovascular disease (ASCVD)) and control (not diagnosed with ASCVD). The participants will have whole blood and serum collected at enrollment for further biobanking. A genome-wide association study will be carried out to determine the genetic determinants associated with atherosclerosis, coronary heart disease, acute coronary syndrome, etc., including a search for pathogenic variants.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. At least 18 years of age;
  2. Informed consent;
  3. An in-patient available for a comprehensive assessment for ASCVD.

Exclusion

Exclusion criteria:

  1. Refusal to participate;
  2. Positive/negative ASCVD impossible to confirm;
  3. HIV, syphilis, hepatitis B and C;
  4. Any other criteria deemed reasons for exclusion by the Principal Investigator

Study Design

Total Participants: 10000
Study Start date:
November 24, 2021
Estimated Completion Date:
December 31, 2025

Study Description

This is a non-interventional case-control study aimed at identifying the genetic markers associated with various ASCVD types or with the protective effect against them. Participants are being recruited at the National Medical Research Center for Cardiology of the Ministry of Health of Russia. The study will comprise at least 10,000 participants, 1 non-ASCVD patient per 2 ASCVD patients. The recruitment period started in September 2021 and will continue till December 2023. The study will be conducted for 29 months. Observation will be carried out throughout the study.

The participants of this study will be selected from the patients of the inpatient treatment at the National Medical Research Center of Cardiology. This study procedures will have no effect on the diagnostic and therapeutic procedures implemented by the attending physicians, based on the protocols and recommendations adopted in the Russian Federation.

All participants will be divided into 2 groups:

  1. Patients with severe atherosclerosis (≥ 50% stenosis caused by atherosclerotic plaque) of various vascular beds (coronary vessels, carotid arteries, mesenteric arteries, lower extremities, and kidneys)

  2. Control group without clinically significant atherosclerotic lesions (≤49% stenosis).

In each group, the known risk factors and the genetic determinants of ASCVD will be investigated. Based on the results of the analysis of all factors under consideration, the study should yield a panel of ASCVD markers.

Connect with a study center

  • Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency

    Moscow, 123182
    Russian Federation

    Active - Recruiting

  • National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation

    Moscow, 121552
    Russian Federation

    Active - Recruiting

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