Coronary Artery DiseaseCROWN-SAGANCT06749171
Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh at 1 site in Russia.
Trial summary
The aim of this observational single-centre study is the optimization of coronary artery bypass grafting (CABG) tactics considering gender and sex approach on the basis of complex comparative evaluation of surgical revascularization techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease, Coronary Artery Bypass Grafting
- What is being tested?
- coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2016to 1 Feb 2024
- How long will I take part?
- 30 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients were sampled from a cohort of 7945 CABG patients in accordance with the eligibility criteria and time period, followed by use of random number generating method to enrol 200 females and 200 males.
Who may be able to join
- patients with multivessel coronary artery disease requiring CABG;
- age ≥ 18 years;
- patients residing in the Perm region.
Who cannot join
- single-vessel CABG;
- redo CABG;
- concomitant coronary artery disease and caroid artery disease and/or valvular disease and/or rhythm disorders requiring surgical treatment
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov
Perm, Perm Krai, 614013
About this study
Official title: Comparative Analysis of Coronary Revascularization Approaches Within Gender and Sex Aspects
The aim of this observational single-centre study is the optimization of coronary artery bypass grafting (CABG) tactics considering gender and sex approach on the basis of complex comparative evaluation of surgical revascularization techniques. Patients enrolled in the study are divided into groups based on sex, as well as into stratum of surgery techniques.
Objectives of the study are:
- To evaluate the preoperative profile of women and men referred for CABG.
- To give a comparative assessment of CABG outcomes in the short-term and long-term postoperative period in patients of both sexes.
- To carry out the comparative analysis of short-term and long-term outcomes of different CABG techniques for each sex.
- To analyse the causes and identify predictors of complications and mortality after CABG in the female and male cohort.
- To determine an optimal selection strategy of surgical revascularization technique for patients of different sexes based on the conducted comparative gender-sex analysis of modern coronary surgery techniques.
Read the detailed description
This retrospective-prospective single-centre study aims to conduct an in-depth comparative analysis of the impact of preoperative profile and range of surgical techniques in coronary artery bypass grafting (CABG) surgery on short-term and long-term outcomes in women and men.
The study included a sample of 400 patients (200 women and 200 men) who underwent CABG between January 2016 and July 2023. Patients enrolled in the study were divided into groups based on sex with the following propensity score matching (PSM) analysis, as well as into stratum of surgery techniques - ONCAB (on-pump coronary artery bypass grafting), OPCAB (off-pump coronary artery bypass grafting), NTA (no-touch aorta technique), MICSCAB (minimally invasive multiple coronary artery bypass grafting). Furthermore, the impact of multiple arterial grafting (MAG), total arterial revascularization (TAR), composite and sequential grafting on outcomes was analyzed for each sex.
Included patients were evaluated for 112 various parameters of preoperative profile, intraoperative characteristics, in-hospital and long-term postoperative data. Perioperative data was obtained from the centre's digital medical information system. Long-term data was gathered from the regional state health information system by tracking patients' chronology of outpatient visits and complaints, subsequent hospital admissions, clinical and laboratory tests.
- Being tested
- coronary artery bypass grafting
- Keywords
- coronary artery bypass grafting, revascularization, OPCAB, ONCAB, NTA, MICSCAB, multiple arterial grafting, sequential grafts, composite grafts, cardiac surgery, women, sex, gender
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass graftingProcedure or surgery
ONCAB (on-pump coronary artery bypass grafting), OPCAB (off-pump coronary artery bypass grafting), NTA (no-touch aorta technique), MICSCAB (minimally invasive multiple coronary artery bypass grafting)
| Study group | Role | What they receive |
|---|---|---|
| Women | Women undergoing CABG Receives: Procedure: coronary artery bypass grafting | |
| Men | Men undergoing CABG Receives: Procedure: coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
major adverse cardiac and cerebrovascular events - composite of all-cause mortality, myocardial infarction (MI), stroke or transient ischaemic attack (TIA) and repeat revascularization
Measured: from date of hospital discharge until the date of first documented major adverse cardiac and cerebrovascular event, through study completion, up to an average of 30 months
Secondary outcomes (1)
Death
all-cause mortality
Measured: from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2016
- Primary completion31 Jul 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Enrolment
- 400 participants (actual)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilothia Sofia Harishevna, Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749171
- Sponsor's protocol ID
- CROWN-SAGA
- Acronym
- CROWN-SAGA
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lilothia S.H. Timeline of scientific knowledge in the field of coronary artery bypass surgery focusing in the gender and sex perspective. Complex Issues of Cardiovascular Diseases. 2024;13(2): 196-202. DOI: 10.17802/2306-1278-202413-2-196-202
Lilothia S. H. Gender inequality and cardiovascular diseases. Russian Journal of Cardiology. 2024;29(6):5873. doi: 10.15829/1560-4071-2024-5873. EDN LPEYQM
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Coronary Revascularization Approaches Within Gender and Sex Aspects
- ClinicalTrials.gov ID
- NCT06749171
- Acronym / sponsor ID
- CROWN-SAGA / CROWN-SAGA
- Keywords
- coronary artery bypass grafting, revascularization, OPCAB, ONCAB, NTA, MICSCAB, multiple arterial grafting, sequential grafts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. SukhUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 27 Dec 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.
The aim of this observational single-centre study is the optimization of coronary artery bypass grafting (CABG) tactics considering gender and sex approach on the basis of complex comparative evaluation of surgical revascularization techniques. Patients enrolled in the study are divided into groups based on sex, as well as into stratum of surgery techniques.
Objectives of the study are:
- To evaluate the preoperative profile of women and men referred for CABG.
- To give a comparative assessment of CABG outcomes in the short-term and long-term postoperative period in patients of both sexes.
- To carry out the comparative analysis of short-term and long-term outcomes of different CABG techniques for each sex.
- To analyse the causes and identify predictors of complications and mortality after CABG in the female and male cohort.
- To determine an optimal selection strategy of surgical revascularization technique for patients of different sexes based on the conducted comparative gender-sex analysis of modern coronary surgery techniques.
Detailed description
This retrospective-prospective single-centre study aims to conduct an in-depth comparative analysis of the impact of preoperative profile and range of surgical techniques in coronary artery bypass grafting (CABG) surgery on short-term and long-term outcomes in women and men.
The study included a sample of 400 patients (200 women and 200 men) who underwent CABG between January 2016 and July 2023. Patients enrolled in the study were divided into groups based on sex with the following propensity score matching (PSM) analysis, as well as into stratum of surgery techniques - ONCAB (on-pump coronary artery bypass grafting), OPCAB (off-pump coronary artery bypass grafting), NTA (no-touch aorta technique), MICSCAB (minimally invasive multiple coronary artery bypass grafting). Furthermore, the impact of multiple arterial grafting (MAG), total arterial revascularization (TAR), composite and sequential grafting on outcomes was analyzed for each sex.
Included patients were evaluated for 112 various parameters of preoperative profile, intraoperative characteristics, in-hospital and long-term postoperative data. Perioperative data was obtained from the centre's digital medical information system. Long-term data was gathered from the regional state health information system by tracking patients' chronology of outpatient visits and complaints, subsequent hospital admissions, clinical and laboratory tests.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | Procedure: coronary artery bypass graftingWomen undergoing CABG |
| Men | – | Procedure: coronary artery bypass graftingMen undergoing CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were sampled from a cohort of 7945 CABG patients in accordance with the eligibility criteria and time period, followed by use of random number generating method to enrol 200 females and 200 males.
Key inclusion criteria (3 listed)
- patients with multivessel coronary artery disease requiring CABG;
- age ≥ 18 years;
- patients residing in the Perm region.
Key exclusion criteria (3 listed)
- single-vessel CABG;
- redo CABG;
- concomitant coronary artery disease and caroid artery disease and/or valvular disease and/or rhythm disorders requiring surgical treatment
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 graftingONCAB (on-pump coronary artery bypass grafting), OPCAB (off-pump coronary artery bypass grafting), NTA (no-touch aorta technique), MICSCAB (minimally invasive multiple coronary artery bypass grafting) | Procedure or surgery | Men, Women |
Primary outcome
MACCE
Time frame: from date of hospital discharge until the date of first documented major adverse cardiac and cerebrovascular event, through study completion, up to an average of 30 months
major adverse cardiac and cerebrovascular events - composite of all-cause mortality, myocardial infarction (MI), stroke or transient ischaemic attack (TIA) and repeat revascularization
1 secondary outcome
Death
Time frame: from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- BackgroundLilothia S.H. Timeline of scientific knowledge in the field of coronary artery bypass surgery focusing in the gender and sex perspective. Complex Issues of Cardiovascular Diseases. 2024;13(2): 196-202. DOI: 10.17802/2306-1278-202413-2-196-202
- BackgroundLilothia S. H. Gender inequality and cardiovascular diseases. Russian Journal of Cardiology. 2024;29(6):5873. doi: 10.15829/1560-4071-2024-5873. EDN LPEYQM
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh at 1 site 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 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: from date of hospital discharge until the date of first documented major adverse cardiac and cerebrovascular event, through study completion, up to an average of 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749171, which also lists 2 linked publications.
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 27 Dec 2024.