Genetics of Cardiovascular Disease (GCVD)

Center for Strategic Planning, of the Federal Medical and Biological Agency

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06253481

Cardiogen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

10,000 participants in 2 patient groups

Group I: patients diagnosed with various types of ASCVD

Description:

Group I: Patients diagnosed with various types of ASCVD (\> 50% stenosis caused by atherosclerotic plaque) of various vascular beds (coronary vessels, carotid arteries, mesenteric arteries, lower extremities, and kidneys) (case; n=6500).

Group II: patients with no clinically significant ASCVD (control, n=3500)

Description:

Group II: patients with no ultrasound/ angiography findings of ASCVD (control, n=3500)