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Coronary Arterial Disease (CAD)NCT06784609

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

An observational study of Coronary Arterial Disease (CAD) and Fraility, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Coronary Artery Bypass Surgery
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Sep 2024to 1 Apr 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Basaksehir Cam ve Sakura City Hospital

    Istanbul, Başakşehir, 34480

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

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.

The STS scoring system was developed in 1994 and is a widely used system in the world that allows for the evaluation of morbidity as well as expected mortality for open heart surgery. The Euroscore -II system is also one of the most widely used systems in this field. Both methods are simple, accurate, provable and inexpensive.

In the assessment of frailty, the Clinical Frailty Scale (CFS) was first introduced by Rockwood and colleagues in 2005. This scale was modified by Pulok and colleagues in 2020. CFS is shown to be the most practical method (can be completed in less than a minute) that can also be applied in the field of Emergency Medicine. In 1963, Katz developed the Katz Activities of Daily Living (ADL) Scale, which shows how independently older individuals can perform daily activities. Although frailty is defined as related to aging, it has been accepted as a concept independent of age in recent years.

When evaluated histopathologically, changes such as hypertrophy, fibrosis, protein misfolding, and accumulation of dysfunctional mitochondria have been shown in the aging heart. Age-related changes in the heart are thought to be due to oxidative stress, non-enzymatic glycation, inflammation, and changes in cardiovascular gene expression. Age is a risk factor for the development of many diseases, and it has been shown that frail individuals have a higher susceptibility to disease than healthy individuals of the same age.

The investigators aimed to demonstrate the histopathological prediction degree and corresponding value of risk scores and fragility index values on cardiac tissue and to demonstrate the reality and importance of these scoring systems at the tissue level and to evaluate their reliability in predicting postoperative mortality and morbidity development. In addition, the investigators aimed to reveal the relationship of fragility tests with both age and STS and Euroscore-II by examining the compatibility of age-related changes detected histopathologically with chronological age.

The tests to be used for this study are routine tests and there is no risk. The cardiac tissue to be used for histopathological examination is tissue pieces that are dissected from the right atrial appendage while removing the venous cannula and routinely removed from the body and sent for histopathological examination. Since no non-routine tissue or blood sample will be taken from the patient, there is no risk.

Being tested
Coronary Artery Bypass Surgery
Keywords
coronary arterial disease, cad, coronary artery bypass, coronary, fraility, histopathology, cardiac risk factors, mortality, morbidities, bypass, preoperative cardiac surgery patients
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Artery Bypass SurgeryProcedure or surgery

    Coronary Artery Bypass Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within the following month after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start5 Sep 2024
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784609
Sponsor's protocol ID
KAEK-11/28.08.2024.133
Status last verified
Jan 2025
First submitted
6 Sep 2024
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD) and Fraility, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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?

Cardiac Histopathological Examination (time frame: Within the following month after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jan 2025.

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Clinical Trial NCT06784609 | AzTrials