Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects
NCT ID: NCT06749171
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2016-01-01
2024-02-01
Brief Summary
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Objectives of the study are:
1. To evaluate the preoperative profile of women and men referred for CABG.
2. To give a comparative assessment of CABG outcomes in the short-term and long-term postoperative period in patients of both sexes.
3. To carry out the comparative analysis of short-term and long-term outcomes of different CABG techniques for each sex.
4. To analyse the causes and identify predictors of complications and mortality after CABG in the female and male cohort.
5. 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
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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.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Women
Women undergoing CABG
coronary artery bypass grafting
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)
Men
Men undergoing CABG
coronary artery bypass grafting
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)
Interventions
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coronary artery bypass grafting
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)
Eligibility Criteria
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Inclusion Criteria
* age ≥ 18 years;
* patients residing in the Perm region.
Exclusion Criteria
* redo CABG;
* concomitant coronary artery disease and caroid artery disease and/or valvular disease and/or rhythm disorders requiring surgical treatment
18 Years
ALL
No
Sponsors
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Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh
OTHER
Responsible Party
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Lilothia Sofia Harishevna
MD, Cardiovascular Surgeon
Locations
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Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov
Perm, Perm Kray, Russia
Countries
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References
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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
Other Identifiers
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CROWN-SAGA
Identifier Type: -
Identifier Source: org_study_id