to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass GraftingNCT06215300
The Effect of Polymorphism of the GUCY1A3 rs7692387 Gene on Cardiovascular Events After Coronary Artery Bypass Grafting.
An observational study of to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass Grafting, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 2 sites in Russia.
Trial summary
Polymorphism in the GUCY1A3 gene worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. Studies have shown the association of the GUCY1A3 gene with the risk of coronary heart disease and its complications, with ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass Grafting
- What is being tested?
- coronary artery bypass grafting
- How many people
- 800 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Dec 2022to 1 Nov 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with IHD
Who may be able to join
- Stable ischemic disease 2- 4
- CABG
Who cannot join
- the need to take any anticoagulants
- thrombocytopenia
- allergy to aspirin.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Novosibirsk research institute of circulation pathology
Novosibirsk, Novosibirsk Oblast, 630055
Alexander Edemskiy, MD, +79139160665, aeskander@yandex.ru
- Recruiting
Aleksey
Novosibirsk
Aleksey Kurguzov, +79137011917, a_kurguzov@meshalkin.ru
About this study
Polymorphism in the GUCY1A3 gene worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. Studies have shown the association of the GUCY1A3 gene with the risk of coronary heart disease and its complications, with ischemic stroke
Read the detailed description
Acetylsalicylic acid is indicated for the prevention of cardiovascular complications after CABG. Class I. The level of evidence A. ECS recommendations, Russian recommendations of cardiologists. However, the main problem of CABG remains thrombotic and thromboembolic complications in the immediate and long-term postoperative period, despite taking acetylsalicylic acid. According to various sources, the resistance to ASA among the population ranges from 5 to 45%. Resistance to ASA is primarily associated with genetic factors: the presence of polymorphisms of genes encoding platelet receptor proteins, and the functional activity of soluble guanylate cyclase (rCC), the synthesis of which is controlled by the GUCY1A3 gene. Studies have shown a link between the GUCY1A3 gene and the risk of coronary heart disease and its complications. The presence of polymorphism in the GUCY1A3 gene significantly worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. At the same time, acetylsalicylic acid cannot provide effective prevention of thrombotic and thromboembolic complications.
- Being tested
- coronary artery bypass grafting
- Keywords
- cardiovascular system, coronary artery bypass grafting, aspirin resistance, GUCY1A3 gene polymorphism rs7692387, soluble guanylate cyclase (rGC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass graftingGenetic
coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| genotype GG | GG Receives: Genetic: coronary artery bypass grafting | |
| genotype AG/АА | AG/АА Receives: Genetic: coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes.
myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Dec 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass GraftingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory Pathology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215300
- Sponsor's protocol ID
- GUCY1A3 rs7692387
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Polymorphism of the GUCY1A3 rs7692387 Gene on Cardiovascular Events After Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT06215300
- Acronym / sponsor ID
- GUCY1A3 rs7692387
- Keywords
- cardiovascular system, coronary artery bypass grafting, aspirin resistance, GUCY1A3 gene polymorphism rs7692387, soluble guanylate cyclase (rGC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory PathologyUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 22 Jan 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.
Polymorphism in the GUCY1A3 gene worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. Studies have shown the association of the GUCY1A3 gene with the risk of coronary heart disease and its complications, with ischemic stroke
Detailed description
Acetylsalicylic acid is indicated for the prevention of cardiovascular complications after CABG. Class I. The level of evidence A. ECS recommendations, Russian recommendations of cardiologists. However, the main problem of CABG remains thrombotic and thromboembolic complications in the immediate and long-term postoperative period, despite taking acetylsalicylic acid. According to various sources, the resistance to ASA among the population ranges from 5 to 45%. Resistance to ASA is primarily associated with genetic factors: the presence of polymorphisms of genes encoding platelet receptor proteins, and the functional activity of soluble guanylate cyclase (rCC), the synthesis of which is controlled by the GUCY1A3 gene. Studies have shown a link between the GUCY1A3 gene and the risk of coronary heart disease and its complications. The presence of polymorphism in the GUCY1A3 gene significantly worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. At the same time, acetylsalicylic acid cannot provide effective prevention of thrombotic and thromboembolic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| genotype GG | – | Genetic: coronary artery bypass graftingGG |
| genotype AG/АА | – | Genetic: coronary artery bypass graftingAG/АА |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with IHD
Key inclusion criteria (2 listed)
- Stable ischemic disease 2- 4
- CABG
Key exclusion criteria (3 listed)
- the need to take any anticoagulants
- thrombocytopenia
- allergy to aspirin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary artery bypass graftingcoronary artery bypass grafting | Genetic | genotype AG/АА, genotype GG |
Primary outcome
myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes.
Time frame: 12 months
myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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.
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 to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass Grafting, run by Novosibirsk Scientific Research Institute for Circulatory Pathology 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 2 inclusion and 3 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 22 Jan 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 Aleksey Kurguzov, MD (+79137011917, aleksey_kurguzov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes. (time frame: 12 months). 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 22 Jan 2024.