Correlation of Euroscore-II, STS Risk Scoring Systems and Frailty Tests with Cardiac Histopathological Findings in Coronary Bypass Surgery

NCT06784609 | Active Not Recruiting DMC

• 1 other identifier: KAEK-11/28.08.2024.133
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Various risk classification systems are used to predict postoperative mortality and morbidity development in cardiac surgery. Risk calculation with these systems is a guide in determining preoperative strategies, performing cost analyses, creating different treatment options and classifying diseases according to their severity. In recent years, tests defined as Frailty, which show how independently a person can perform daily living activities and are also associated with postoperative complications, have also been used. These tests allow for a personalized approach such as determining the most appropriate treatment options and pre- and postoperative rehabilitation. This study aims to evaluate the risk scores used to predict mortality during the preoperative preparation process in cases planned for elective Coronary Artery Bypass Graft (CABG) using the European System for Cardiac Operative Risk Evaluation (Euroscore)-II and Society of Thoracic Surgeons (STS) as well as Frailty with the Katz Index and modified Rockwood Clinical Frailty Scale, and to correlate the findings obtained from the histopathological study of the tissue sample taken from the right atrium during the operation with the test results. Secondary objectives are to investigate the compatibility of the age-related changes detected histopathologically with chronological age, to reveal which of the Frailty tests used gives better results in predicting mortality, and on the other hand, to reveal the relationship between Frailty tests and STS and Euroscore-II.

Conditions

Coronary Arterial Disease (CAD); Fraility; Histopathology; Cardiac Risk Factors; Mortality; Morbidities; Coronary Artery Bypass; Anesthesia; Preoperative Cardiac Surgery Patients

Keywords

coronary arterial disease; cad; coronary artery bypass; coronary; fraility; histopathology; cardiac risk factors; mortality; morbidities; bypass; preoperative cardiac surgery patients

Outcome Measures

Primary Outcomes (1)

• Cardiac Histopathological Examination

  Within the scope of histopathological examination; inflammation and fibrosis criteria in cardiac tissue will be evaluated by the Pathologist and will be interpreted by grading as 0, 1, 2, 3.

  Within the following month after the procedure

Other Outcomes (2)

• Cardiac Risks Scoring Systems

  At the first day of enrollment

• Fraility Tests

  At the first day of enrollment

Interventions

Coronary Artery Bypass Surgery PROCEDURE

Coronary Artery Bypass Surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients between the ages of 40 and 80, * Under general anesthesia, planned for elective isolated CABG.

You may qualify if:

• Patients between the ages of 40 and 80,
• Under general anesthesia, planned for elective isolated CABG.

You may not qualify if:

• Under the age of 40, over the age of 80,
• Emergency cases,
• Reoperations,
• Patients with EF ≤ 25%,
• Patients with vasculitis, rheumatological diseases and connective tissue diseases.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zulfiye Yildiz M.D.

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: January 20, 2025
• Study Start: September 5, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)