Genetics of Cardiovascular Disease

Atrial Fibrillation Clinical Trial

— GCVD  

Official title:

Cardiovascular Diseases: Investigating the Risk Factors and Clinical Features Using Multi-omics Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253481
• Other study ID #: Cardiogen
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atrial Fibrillation
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

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