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

NCT05603429 | Completed

• 1 other identifier: HNEAH-KAEK 2022/43-3507
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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)

  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)

  through study completion, an average of 1 year

Study Arms (4)

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

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

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

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

Interventions

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status DIAGNOSTIC_TEST

Endocan, E-Selectin, TNF-alpha, Total Oxidant and Antioxidant Status measurements for determining Endothelial Damage and Oxidative Stress

AVR with Del Nido; AVR with cold blood cardioplegia; CABG with Del Nido; CABG with cold blood cardioplegia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: lead

Study Sites (1)

Dr. Siyami Ersek Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (4)

• Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652.

  PMID: 28863040 BACKGROUND

• O'Blenes SB, Friesen CH, Ali A, Howlett S. Protecting the aged heart during cardiac surgery: the potential benefits of del Nido cardioplegia. J Thorac Cardiovasc Surg. 2011 Mar;141(3):762-70. doi: 10.1016/j.jtcvs.2010.06.004. Epub 2010 Jul 24.

  PMID: 20656301 BACKGROUND

• Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.

  PMID: 29246552 BACKGROUND

• Orak Y, Kocarslan A, Boran OF, Acipayam M, Eroglu E, Kirisci M, Doganer A. Comparison of the operative and postoperative effects of del Nido and blood cardioplegia solutions in cardiopulmonary bypass surgery. Braz J Cardiovasc Surg. 2020 Oct 1;35(5):689-696. doi: 10.21470/1678-9741-2019-0436.

  PMID: 33118734 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood specimens taken from peripheral venous cannula and retrograde cardioplegia cannula

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bulend KETENCI

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: November 2, 2022
• Study Start: October 13, 2022
• Primary Completion: July 25, 2023
• Study Completion: August 8, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

TU (1)