Genetics of Cardiovascular Disease

NCT06253481 | Recruiting DMC

• 1 other identifier: Cardiogen
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Atherosclerosis; Coronary Heart Disease; Myocardial Infarction; Atrial Fibrillation

Keywords

Atherosclerosis; coronary heart disease; myocardial infarction; atrial fibrillation; polygenic risk panel; multi-omics study

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In-patients of the National Medical Research Center for Cardiology from various regions of the Russian Federation.

You may qualify if:

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

You may not qualify if:

• Refusal to participate;
• Positive/negative ASCVD impossible to confirm;
• HIV, syphilis, hepatitis B and C;

Sponsors & Collaborators

• Center for Strategic Planning, of the Federal Medical and Biological Agency: lead
• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation: collaborator

Study Sites (2)

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

Moscow, 121552, Russia

RECRUITING

Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency

Moscow, 123182, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Atherosclerosis; Coronary Disease; Myocardial Infarction; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac

Study Officials

• 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

Central Study Contacts

Veronika V. Erema, M.D., Ph.D

CONTACT

+7 (495) 540-61-71; VErema@cspfmba.ru

Daria A Kashtanova, M.D., Ph.D

CONTACT

+7 (495) 540-61-71; dr.kashtanova@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: November 24, 2021
• Primary Completion: November 24, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)