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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06253481
Other study ID # Cardiogen
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Center for Strategic Planning, of the Federal Medical and Biological Agency
Contact Veronika V. Erema, M.D., Ph.D
Phone +7 (495) 540-61-71
Email VErema@cspfmba.ru
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 31, 2025
Est. primary completion date November 24, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Russian Federation 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

Sponsors (2)

Lead Sponsor Collaborator
Center for Strategic Planning, of the Federal Medical and Biological Agency National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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