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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05603429
Enrollment
74
Registered
2022-11-02
Start date
2022-10-13
Completion date
2023-08-08
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Bypass Complication, Cardioplegia Solution Adverse Reaction, Coronary Artery Disease, Endothelial Degeneration, Oxidative Stress

Keywords

Coronary Artery Bypass Grafting, Cardioplegia, Cardiopulmonary Bypass, Aortic Valve Replacement, Endothelial Damage, Oxidative Stress

Brief summary

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.

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

Interventions

DIAGNOSTIC_TESTEndocan, 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Del Nido has beneficial effect for Endothelial functionthrough study completion, an average of 1 yearTwo 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
Del Nido cardioplegia solution has lesser oxidative effect comparing to blood cardioplegiathrough study completion, an average of 1 yearTwo 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
SYNTAX effect (SYNergy between PCI{Percutaneous Coronary Intervention} with TAXUS and Cardiac. Surgery)through study completion, an average of 1 yearThe 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)
LVMI effectthrough study completion, an average of 1 yearIn 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026