AtherosclerosisGCVDNCT06253481
Genetics of Cardiovascular Disease
An observational study of Atherosclerosis and Coronary Heart Disease, run by Center for Strategic Planning, of the Federal Medical and Biological Agency at 2 sites in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Heart Disease, Myocardial Infarction
- How many people
- 10,000 participants
- Where
- 2 sitesRussia
- Study dates
- 24 Nov 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: In-patients of the National Medical Research Center for Cardiology from various regions of the Russian Federation.
Who may be able to join
- At least 18 years of age;
- Informed consent;
- An in-patient available for a comprehensive assessment for ASCVD.
Who cannot join
- Refusal to participate;
- Positive/negative ASCVD impossible to confirm;
- HIV, syphilis, hepatitis B and C;
- Any other criteria deemed reasons for exclusion by the Principal Investigator
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation
Moscow, 121552
Marat V Erema, M.D., Ph.D, +7 (495) 414 60 67, Marat_Ezhov@mail.ru
- Recruiting
Federal State Budgetary Institution Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency
Moscow, 123182
Veronika Erema V Erema, M.D., Ph.D, +7 (495) 540-61-71 ext. 4136, VErema@cspfmba.ru
Daria A Kashtanova, M.D., Ph.D, +7 (495) 540-61-71 ext. 4120, DKashtanova@cspfmba.ru
About this study
Official title: Cardiovascular Diseases: Investigating the Risk Factors and Clinical Features Using Multi-omics Technologies
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.
Read the 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:
- Patients with severe atherosclerosis (≥ 50% stenosis caused by atherosclerotic plaque) of various vascular beds (coronary vessels, carotid arteries, mesenteric arteries, lower extremities, and kidneys)
- 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.
- Keywords
- Atherosclerosis; coronary heart disease; myocardial infarction; atrial fibrillation; polygenic risk panel; multi-omics study
- Medical subject headings
- Atherosclerosis, Coronary Disease, Myocardial Infarction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start24 Nov 2021
- Primary completion24 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Strategic Planning, of the Federal Medical and Biological Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Responsible party
- Sponsor
- Investigators
- Marat V. Ezhov, M.D., Ph.D, Principal investigator, National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253481
- Sponsor's protocol ID
- Cardiogen
- Acronym
- GCVD
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Diseases: Investigating the Risk Factors and Clinical Features Using Multi-omics Technologies
- ClinicalTrials.gov ID
- NCT06253481
- Acronym / sponsor ID
- GCVD / Cardiogen
- Keywords
- Atherosclerosis; coronary heart disease; myocardial infarction; atrial fibrillation; polygenic risk panel; multi-omics study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Center for Strategic Planning, of the Federal Medical and Biological AgencyUniversity, hospital or other
- Collaborators
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 24 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with severe atherosclerosis (≥ 50% stenosis caused by atherosclerotic plaque) of various vascular beds (coronary vessels, carotid arteries, mesenteric arteries, lower extremities, and kidneys)
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In-patients of the National Medical Research Center for Cardiology from various regions of the Russian Federation.
Key inclusion criteria (3 listed)
- At least 18 years of age;
- Informed consent;
- An in-patient available for a comprehensive assessment for ASCVD.
Key exclusion criteria (4 listed)
- Refusal to participate;
- Positive/negative ASCVD impossible to confirm;
- HIV, syphilis, hepatitis B and C;
- Any other criteria deemed reasons for exclusion by the Principal Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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.
Time frame: up to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marat V. Ezhov, M.D., Ph.D principal investigator
National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Heart Disease, run by Center for Strategic Planning, of the Federal Medical and Biological Agency at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veronika V. Erema, M.D., Ph.D (+7 (495) 540-61-71 ext. 4136, VErema@cspfmba.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 24 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.