An observational study in Bypass Complication, Cardioplegia Solution Adverse Reaction and Endothelial Degeneration, sponsored by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital · Observational
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.
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
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 74 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively
Exclusion Criteria:
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
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
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
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
Del Nido has beneficial effect for Endothelial function
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
Time frame: through study completion, an average of 1 year
Del Nido cardioplegia solution has lesser oxidative effect comparing to blood cardioplegia
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
Time frame: through study completion, an average of 1 year
SYNTAX effect (SYNergy between PCI{Percutaneous Coronary Intervention} with TAXUS and Cardiac. Surgery)
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)
Time frame: through study completion, an average of 1 year
LVMI effect
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)
Time frame: through study completion, an average of 1 year
Plan to share: Undecided
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Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital