Coronary Revascularization Outcomes Within Necessary Sex and Gender Aspects

NCT06749171 | Completed

• 1 other identifier: CROWN-SAGA
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.To evaluate the preoperative profile of women and men referred for CABG.
2. 2.To give a comparative assessment of CABG outcomes in the short-term and long-term postoperative period in patients of both sexes.
3. 3.To carry out the comparative analysis of short-term and long-term outcomes of different CABG techniques for each sex.
4. 4.To analyse the causes and identify predictors of complications and mortality after CABG in the female and male cohort.
5. 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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease; 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

Outcome Measures

Primary Outcomes (1)

• MACCE

  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 Outcomes (1)

• Death

  from date of hospital discharge until the date of death from any cause, through study completion, up to an average of 30 months

Study Arms (2)

Women

Women undergoing CABG

Procedure: coronary artery bypass grafting

Men

Men undergoing CABG

Procedure: coronary artery bypass grafting

Interventions

coronary artery bypass grafting PROCEDURE

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; Women

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Federal Centre for Cardiovascular Surgery n.a. S.G. Sukhanov

Perm, Perm Kray, 614013, Russia

Location

Related Publications (2)

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coitus

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Cardiovascular Surgeon

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2016
• Primary Completion: July 31, 2023
• Study Completion: February 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)