Clinical trial NCT06253481: Genetics of Cardiovascular Disease
Official title: Cardiovascular Diseases: Investigating the Risk Factors and Clinical Features Using Multi-omics Technologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Coronary Heart Disease
Myocardial Infarction
Atrial Fibrillation
Keywords: Atherosclerosis; coronary heart disease; myocardial infarction; atrial fibrillation; polygenic risk panel; multi-omics study
Lead sponsor: Center for Strategic Planning, of the Federal Medical and Biological Agency
Sponsor class: OTHER
Collaborators: name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
First posted: 2024-02-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patients of the National Medical Research Center for Cardiology from various regions of the Russian Federation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 24 month
measure: 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.
timeFrame: up to 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency
Study officials:
affiliation: National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation
name: Marat V. Ezhov, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: