Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: patients diagnosed with various types of ASCVD | 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) | Group II: patients with no ultrasound/ angiography findings of ASCVD (control, n=3500) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
In-patients of the National Medical Research Center for Cardiology from various regions of the Russian Federation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronika V. Erema, M.D., Ph.D | Contact | +7 (495) 540-61-71 | 4136 | VErema@cspfmba.ru |
| Daria A Kashtanova, M.D., Ph.D | Contact | +7 (495) 540-61-71 | 4120 | dr.kashtanova@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marat V. Ezhov, M.D., Ph.D | National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation | Recruiting | Moscow | 121552 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003327 | Coronary Disease |
| D009203 | Myocardial Infarction |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood, serum
| Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency | Recruiting | Moscow | 123182 | Russia |
|
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |