Genetics of Cardiovascular Disease

Recruiting

• Conditions: Coronary Heart Disease; Atherosclerosis; Myocardial Infarction; Atrial Fibrillation

• Registration Number: NCT06253481
• Lead Sponsor: Center for Strategic Planning, of the Federal Medical and Biological Agency

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-24
• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-11-24
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of the genetic determinant associated with ASCVD, coronary heart disease, and myocardial infarction; 1) Identification of the genetic determinant associated with ASCVD, coronary heart disease, and myocardial infarction	up to 24 month
Determining the frequency of the pathogenic variants in the study cohort, including in the participants with the early onset of atrial fibrillation, myocardial infarction, and carotid artery disease, etc.	up to 24 month

Trial Locations

Locations (2)

Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency; 🇷🇺 Moscow, Russian Federation

National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation; 🇷🇺 Moscow, Russian Federation