Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery

August 8, 2023 updated by: Fatih KIZILYEL, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Investigation of Myocardial Protection Level by Oxidative Stress and Endothelial Damage With Two Cardioplegia Methods Used During Cardiac Surgery

Investigating the myocardial effects of cold blood cardioplegia and del nido cardioplegia solution, which are routinely used in clinical practice, will contribute to the studies in the literature on the safety and efficacy of these two methods.

For this purpose, patients with coronary artery disease that going to be Coronary Artery Bypass Graft (CABG) surgery will be classified within the scope of the SYNTAX score, the level of exposure to cardioplegia change in proportion to their score will be examined. Also, left ventricular muscle mass will be calculated in patients who will undergo Aortic Valve replacement (AVR) due to Aortic Stenosis, and myocardial protection level proportional to muscle mass will be examined, and cardioplegia efficiency will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endocan, E-Selectin, TNF(Tumor Necrosis Factor)-alpha, Total Oxidant and Antioxidant status will be studied on sequential blood samples taken from patients who will undergo Elective Coronary Artery Bypass Grafting operation and aortic valve replacement, via retrograde cardioplegia cannula before induction, at the beginning of cardiopulmonary bypass and after removing the cross-clamp. With routinely used parameters like hemogram, lactate, liver and kidney function tests morbidity-mortality rates for specific cardioplegia technique will be compared

Study Type

Observational

Enrollment (Actual)

74

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

  • Turkey
      • Istanbul, Turkey, 34668
        • Dr. Siyami Ersek Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively

Description

Inclusion Criteria:

  • Subjects planned to have elective coronary artery bypass grafting for coronary artery disease
  • Subjects planned to have elective aortic valve surgery due to aortic valve stenosis
  • Patients aged 18-75 years
  • BMI of 18.5-30
  • Diabetic and non-diabetic patients
  • Smokers and non-smokers

Exclusion Criteria:

  • Subjects under 18 years old
  • Subjects older than 75 years
  • Patients requiring valve surgery with coronary artery bypass
  • Patients requiring aortic valve surgery with pathologies other than aortic valve stenosis
  • Patients requiring mitral or tricuspid valve surgery
  • Patients undergoing emergency coronary bypass
  • BMI > 30 obese patients

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
CABG with cold blood cardioplegia
Subjects undergo Elective Coronary Artery Bypass Grafting with the use of cold blood cardioplegia solution for myocardial protection
Diagnostic test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress
CABG with Del Nido
Subjects undergo Elective Coronary Artery Bypass Grafting with the use of Del Nido cardioplegia solution as myocardial protection
Diagnostic test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress
AVR with cold blood cardioplegia
Subjects undergo Aortic Valve Replacement with the use of cold blood cardioplegia solution as myocardial protection
Diagnostic test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress
AVR with Del Nido
Subjects undergo Aortic Valve Replacement with the use of Del Nido cardioplegia solution as myocardial protection
Diagnostic test: Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status
Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Del Nido has beneficial effect for Endothelial function
Time Frame: through study completion, an average of 1 year

Two groups with the protection of Del Nido cardioplegia solution, might have lesser Adverse outcomes from cardiopulmonary bypass and cross-clamping irrespectively, with measurements of BLOOD ENDOCAN (ng/ml) and E-SELECTIN LEVELS measured from venous blood specimens.

Endocan and E-selectin levels to be measured by ELISA (ng/ml), expected to be much higher in the blood cardioplegia group because of the protective affect of Del nido cardioplegia.

The venous blood specimens are going to be collected on different operation phases; after cannulation just before the beginning of cardiopulmonary bypass, after removing the cross-clamp before decannulation
through study completion, an average of 1 year
Del Nido cardioplegia solution has lesser oxidative effect comparing to blood cardioplegia
Time Frame: through study completion, an average of 1 year
Two groups with the protection of Del Nido cardioplegia solution, expected to be lesser oxidative affect with comparing of the TOTAL OXIDANT AND ANTIOXIDANT STATUS measured with specific assay kits from venous blood specimens First venous blood specimen will be taken from peripheral blood, 2nd and 3rd will be taken from coronary sinus blood through retrograde cardioplegia cannula; The venous blood specimens are going to be collected on different operation phases: 1st; after cannulation just before the beginning of cardiopulmonary bypass, 2nd; after removing the cross-clamp before decannulation
through study completion, an average of 1 year
SYNTAX effect (SYNergy between PCI{Percutaneous Coronary Intervention} with TAXUS and Cardiac. Surgery)
Time Frame: through study completion, an average of 1 year

The SYNTAX score has the potential to grade coronary anatomy and to guide patient selection toward the optimal revascularisation treatment to treat complex coronary artery disease (CAD).

Subjects with Coronary Artery Disease might have proportional outcomes with SYNTAX score of individuals based upon parameters measured from venous blood specimens That means one wiht the higher SYNTAX score, expected to have higher difference in the blood cardioplegia group compared to Del Nido cardioplegia group because of the lesser protective affects to the myocardium. (ENDOCAN, E-SELECTIN, TOTAL OXIDANT AND ANTIOXIDANT STATUS measured by specific assay kits)
through study completion, an average of 1 year
LVMI effect
Time Frame: through study completion, an average of 1 year

In patients with severe symptomatic Aortic stenosis, concentric left ventricular(LV) geometry and severe LV hypertrophy by echocardiography have been associated with increased mortality after aortic valve replacement. So, demonstration of the relation of LV mass with myocardial protection levels might be important in the aortic stenosis patients for postoperative morbidity and mortality.

Subjects with Aortic Valve Stenosis might have proportional outcomes with Left Ventricular Mass Index (LVMI) of individuals based upon parameters measured from venous blood specimens. (ENDOCAN, E-SELECTIN, TOTAL OXIDANT AND ANTIOXIDANT STATUS measured by specific assay kits)
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Investigators

  • Study Chair: Bulend KETENCI, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

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

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)

October 13, 2022

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

August 8, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNEAH-KAEK 2022/43-3507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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