Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects (CROWN-SAGA)

December 23, 2024 updated by: Lilothia Sofia Harishevna, Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Perm Kray
      • Perm, Perm Kray, Russian Federation, 614013
        • Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • patients with multivessel coronary artery disease requiring CABG;
  • age ≥ 18 years;
  • patients residing in the Perm region.

Exclusion Criteria:

  • single-vessel CABG;
  • redo CABG;
  • concomitant coronary artery disease and caroid artery disease and/or valvular disease and/or rhythm disorders requiring surgical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women
Women undergoing CABG
Procedure: 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
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
all-cause mortality
from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery named after S.G. Sukh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROWN-SAGA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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