Cardiovascular DiseasesNCT06373549
Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery
An observational study of Cardiovascular Diseases and Myocardial Reperfusion Injury, run by Tamer cebe at 1 site in Turkey (Türkiye).
Trial summary
Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Reperfusion Injury
- What is being tested?
- Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions and Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2022to 24 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Adult Cardiovascular Surgery Clinic will be selected among the patients who will undergo cardiac surgery and meet the inclusion criteria.
Who may be able to join
- Patients who underwent elective coronary artery bypass surgery due to coronary artery disease
- Patients without coronary artery disease who underwent elective valve surgery
- Patients between the ages of 18-75
- Having a BMI of 18.5-30
Who cannot join
- Being under 18 years old
- Patients older than 75 years
- Patients requiring valve surgery (combined surgical procedure) with coronary artery bypass
- Patients who underwent emergency coronary bypass
- BMI > 30 obese patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği
Istanbul, Kadıköy, 34668
About this study
Official title: Investigation of the Protective Effects of Cardioplegia Solutions Used in Open Heart Surgery on Myocardial Redox Homeostasis at the Level of Redox System and Antioxidant System
Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.
Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery.
Read the detailed description
Cardioplegias are routinely used in cardiac surgery to protect the heart from ischemia. Choice of the cardioplegia depends on surgeons clinical experience and preference. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are widely used in clinical practice. There is no clear scientific data in the current literature that demonstrates the superiority of one cardioplegia over the others.
In this study preferred the blood and del Nido cardioplegia solutions, which are commonly used in clinic. Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals.
The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. Hamad et al reported that del Nido and blood cardioplegia solutions offer equivalent safety in combined adult valve surgery. In addition to these differences, the myocardial protective effects of cardioplegias on myocardial redox homeostasis are also among the current research topics. Ischemia and reperfusion injury can be observed in the myocardial tissues of patients undergoing coronary artery bypass graft surgery and isolated valve replacement surgery. It was reported that coronary sinus blood sampling gives an insight into the localized pathophysiology of heart diseases. Comparative research examining the effects of blood and del Nido cardioplegia solutions on coronary sinus redox status is not currently available in the literature. The study aim to contribute to the development of effective strategies to minimize oxidative damage associated with cardiac surgery by investigating the effects of blood and del Nido cardioplegia solutions on coronary sinus redox homeostasis during the preoperative and postoperative periods using redox biomarkers and antioxidant system transcription factors. Thesis project also intend to compare these redox effects with elective isolated valve replacement surgery patients, who do not have coronary artery disease but share a similar pathogenesis with potential strategies for minimizing oxidative damage associated with cardiac surgery using cardiopulmonary bypass (CPB).
- Being tested
- Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions, Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions
- Keywords
- cardioplegia, del Nido, open heart surgery, oxidative stress, redox status
- Medical subject headings
- Cardiovascular Diseases, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutionsProcedure or surgery
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.
Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutionsProcedure or surgery
To investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary artery bypass surgery due to coronary artery disease | From the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes. Receives: Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions; Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions | |
| Patients who underwent heart valve surgery without coronary artery disease | From the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes. Receives: Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions; Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules.
The PCO concentration was expressed as nmol/mg protein. The standard curve was used to express the AOPP concentrations as micromoles per liter of chloramine-T equivalents.Lipid peroxidation rate of coronary sinus blood samples was assessed with a calibration curve for peroxide value using xylenol orange and Fe3+ chloride.
Mitochondrial superoxide dismutase expression.MnSOD concentrations of the coronary sinus blood samples were expressed as ng/mL.GPx activities of the coronary sinus blood samples were expressed as U/mg protein.The CAT activity is measured as the difference in absorbance per unit time.CAT concentrations of the coronary sinus blood samples were expressed as KU/L.The serum Nrf2 levels of the samples were expressed as ng/L.The serum Keap1 levels of the samples were expressed as ng/L.The samples' serum PGC-1α levels were reported as ng/mL.
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start8 Dec 2022
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamer cebe
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Tamer cebe, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373549
- Sponsor's protocol ID
- 2022/183-3896
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the process of obtaining informed consent from the participants involved in the study, it was stated that their data would not be used elsewhere.
Publications
Carvajal C, Goyal A, Tadi P. Cardioplegia. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554463/
PubMed 32119350Comentale G, Giordano R, Palma G. Comparison of the different cardioplegic strategies in cardiac valves surgery: who wins the "arm-wrestling"? J Thorac Dis. 2018 Feb;10(2):714-717. doi: 10.21037/jtd.2018.01.133. No abstract available.
PubMed 29607140Weber C, Jenke A, Chobanova V, Yazdanyar M, Chekhoeva A, Eghbalzadeh K, Lichtenberg A, Wahlers T, Akhyari P, Paunel-Gorgulu A. Targeting of cell-free DNA by DNase I diminishes endothelial dysfunction and inflammation in a rat model of cardiopulmonary bypass. Sci Rep. 2019 Dec 17;9(1):19249. doi: 10.1038/s41598-019-55863-8.
PubMed 31848423Atayik MC, Cakatay U. Redox signaling and modulation in ageing. Biogerontology. 2023 Oct;24(5):603-608. doi: 10.1007/s10522-023-10055-w. Epub 2023 Aug 3.
PubMed 37535201Ulasov AV, Rosenkranz AA, Georgiev GP, Sobolev AS. Nrf2/Keap1/ARE signaling: Towards specific regulation. Life Sci. 2022 Feb 15;291:120111. doi: 10.1016/j.lfs.2021.120111. Epub 2021 Oct 31.
PubMed 34732330Calabrese EJ, Kozumbo WJ. The hormetic dose-response mechanism: Nrf2 activation. Pharmacol Res. 2021 May;167:105526. doi: 10.1016/j.phrs.2021.105526. Epub 2021 Mar 2.
PubMed 33667690GIBBON JH Jr. Application of a mechanical heart and lung apparatus to cardiac surgery. Minn Med. 1954 Mar;37(3):171-85; passim. No abstract available.
PubMed 13154149Topcu AC, Bolukcu A, Ozeren K, Kavasoglu T, Kayacioglu I. Normoxic management of cardiopulmonary bypass reduces myocardial oxidative stress in adult patients undergoing coronary artery bypass graft surgery. Perfusion. 2021 Apr;36(3):261-268. doi: 10.1177/0267659120946733. Epub 2020 Aug 5.
PubMed 32755372Cebe T, Yanar K, Atukeren P, Ozan T, Kuruc AI, Kunbaz A, Sitar ME, Mengi M, Aydin MS, Esrefoglu M, Aydin S, Cakatay U. A comprehensive study of myocardial redox homeostasis in naturally and mimetically aged rats. Age (Dordr). 2014;36(6):9728. doi: 10.1007/s11357-014-9728-y. Epub 2014 Nov 11.
PubMed 25384832Cebe T, Atukeren P, Yanar K, Kuruc AI, Ozan T, Kunbaz A, Sitar ME, Mirmaroufizibandeh R, Aydin S, Cakatay U. Oxidation scrutiny in persuaded aging and chronological aging at systemic redox homeostasis level. Exp Gerontol. 2014 Sep;57:132-40. doi: 10.1016/j.exger.2014.05.017. Epub 2014 May 28.
PubMed 24879971
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Protective Effects of Cardioplegia Solutions Used in Open Heart Surgery on Myocardial Redox Homeostasis at the Level of Redox System and Antioxidant System
- ClinicalTrials.gov ID
- NCT06373549
- Acronym / sponsor ID
- 2022/183-3896
- Keywords
- cardioplegia, del Nido, open heart surgery, oxidative stress, redox status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tamer cebeUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.
Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery.
Detailed description
Cardioplegias are routinely used in cardiac surgery to protect the heart from ischemia. Choice of the cardioplegia depends on surgeons clinical experience and preference. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are widely used in clinical practice. There is no clear scientific data in the current literature that demonstrates the superiority of one cardioplegia over the others.
In this study preferred the blood and del Nido cardioplegia solutions, which are commonly used in clinic. Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals.
The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. Hamad et al reported that del Nido and blood cardioplegia solutions offer equivalent safety in combined adult valve surgery. In addition to these differences, the myocardial protective effects of cardioplegias on myocardial redox homeostasis are also among the current research topics. Ischemia and reperfusion injury can be observed in the myocardial tissues of patients undergoing coronary artery bypass graft surgery and isolated valve replacement surgery. It was reported that coronary sinus blood sampling gives an insight into the localized pathophysiology of heart diseases. Comparative research examining the effects of blood and del Nido cardioplegia solutions on coronary sinus redox status is not currently available in the literature. The study aim to contribute to the development of effective strategies to minimize oxidative damage associated with cardiac surgery by investigating the effects of blood and del Nido cardioplegia solutions on coronary sinus redox homeostasis during the preoperative and postoperative periods using redox biomarkers and antioxidant system transcription factors. Thesis project also intend to compare these redox effects with elective isolated valve replacement surgery patients, who do not have coronary artery disease but share a similar pathogenesis with potential strategies for minimizing oxidative damage associated with cardiac surgery using cardiopulmonary bypass (CPB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary artery bypass surgery due to coronary artery disease | – | Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions, Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutionsFrom the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes. |
| Patients who underwent heart valve surgery without coronary artery disease | – | Procedure: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions, Procedure: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutionsFrom the patients included in the study, blood samples will be taken from the systemic venous circulation before the operation, and from the coronary sinus at 4 minutes before and after the cross-clamp, via a retrograde cardioplegia cannula into yellow capped gel tubes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Adult Cardiovascular Surgery Clinic will be selected among the patients who will undergo cardiac surgery and meet the inclusion criteria.
Key inclusion criteria (4 listed)
- Patients who underwent elective coronary artery bypass surgery due to coronary artery disease
- Patients without coronary artery disease who underwent elective valve surgery
- Patients between the ages of 18-75
- Having a BMI of 18.5-30
Key exclusion criteria (5 listed)
- Being under 18 years old
- Patients older than 75 years
- Patients requiring valve surgery (combined surgical procedure) with coronary artery bypass
- Patients who underwent emergency coronary bypass
- BMI > 30 obese patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutionsTo investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient. | Procedure or surgery | Patients who underwent heart valve surgery without coronary artery disease, Patients with coronary artery bypass surgery due to coronary artery disease |
| Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutionsTo investigate the effectiveness of myocardial protection methods, blood samples were collected from the coronary sinus before the aortic cross-clamping and at 4 minutes after aortic cross-clamping, through a coronary sinus cannula with a yellow-capped gel tube. The collected blood samples were kept in an upright position for 20 minutes to allow separation into serum fraction, then centrifuged at 3000 g for 10 minutes (Beckman Coulter, Microfuge 16, USA). The obtained serums were aliquoted into 250 μl portions in Eppendorf tubes, separately for each patient. | Procedure or surgery | Patients who underwent heart valve surgery without coronary artery disease, Patients with coronary artery bypass surgery due to coronary artery disease |
Primary outcome
Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules.
Time frame: 1-7 days
The PCO concentration was expressed as nmol/mg protein. The standard curve was used to express the AOPP concentrations as micromoles per liter of chloramine-T equivalents.Lipid peroxidation rate of coronary sinus blood samples was assessed with a calibration curve for peroxide value using xylenol orange and Fe3+ chloride. Mitochondrial superoxide dismutase expression.MnSOD concentrations of the coronary sinus blood samples were expressed as ng/mL.GPx activities of the coronary sinus blood samples were expressed as U/mg protein.The CAT activity is measured as the difference in absorbance per unit time.CAT concentrations of the coronary sinus blood samples were expressed as KU/L.The serum Nrf2 levels of the samples were expressed as ng/L.The serum Keap1 levels of the samples were expressed as ng/L.The samples' serum PGC-1α levels were reported as ng/mL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 32119350Carvajal C, Goyal A, Tadi P. Cardioplegia. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554463/
- Background: PubMed 29607140Comentale G, Giordano R, Palma G. Comparison of the different cardioplegic strategies in cardiac valves surgery: who wins the "arm-wrestling"? J Thorac Dis. 2018 Feb;10(2):714-717. doi: 10.21037/jtd.2018.01.133. No abstract available.
- Background: PubMed 31848423Weber C, Jenke A, Chobanova V, Yazdanyar M, Chekhoeva A, Eghbalzadeh K, Lichtenberg A, Wahlers T, Akhyari P, Paunel-Gorgulu A. Targeting of cell-free DNA by DNase I diminishes endothelial dysfunction and inflammation in a rat model of cardiopulmonary bypass. Sci Rep. 2019 Dec 17;9(1):19249. doi: 10.1038/s41598-019-55863-8.
- Background: PubMed 37535201Atayik MC, Cakatay U. Redox signaling and modulation in ageing. Biogerontology. 2023 Oct;24(5):603-608. doi: 10.1007/s10522-023-10055-w. Epub 2023 Aug 3.
- Background: PubMed 34732330Ulasov AV, Rosenkranz AA, Georgiev GP, Sobolev AS. Nrf2/Keap1/ARE signaling: Towards specific regulation. Life Sci. 2022 Feb 15;291:120111. doi: 10.1016/j.lfs.2021.120111. Epub 2021 Oct 31.
- Background: PubMed 33667690Calabrese EJ, Kozumbo WJ. The hormetic dose-response mechanism: Nrf2 activation. Pharmacol Res. 2021 May;167:105526. doi: 10.1016/j.phrs.2021.105526. Epub 2021 Mar 2.
- Background: PubMed 13154149GIBBON JH Jr. Application of a mechanical heart and lung apparatus to cardiac surgery. Minn Med. 1954 Mar;37(3):171-85; passim. No abstract available.
- Background: PubMed 32755372Topcu AC, Bolukcu A, Ozeren K, Kavasoglu T, Kayacioglu I. Normoxic management of cardiopulmonary bypass reduces myocardial oxidative stress in adult patients undergoing coronary artery bypass graft surgery. Perfusion. 2021 Apr;36(3):261-268. doi: 10.1177/0267659120946733. Epub 2020 Aug 5.
- Background: PubMed 25384832Cebe T, Yanar K, Atukeren P, Ozan T, Kuruc AI, Kunbaz A, Sitar ME, Mengi M, Aydin MS, Esrefoglu M, Aydin S, Cakatay U. A comprehensive study of myocardial redox homeostasis in naturally and mimetically aged rats. Age (Dordr). 2014;36(6):9728. doi: 10.1007/s11357-014-9728-y. Epub 2014 Nov 11.
- Background: PubMed 24879971Cebe T, Atukeren P, Yanar K, Kuruc AI, Ozan T, Kunbaz A, Sitar ME, Mirmaroufizibandeh R, Aydin S, Cakatay U. Oxidation scrutiny in persuaded aging and chronological aging at systemic redox homeostasis level. Exp Gerontol. 2014 Sep;57:132-40. doi: 10.1016/j.exger.2014.05.017. Epub 2014 May 28.
- Individual participant dataSharing planned: No. During the process of obtaining informed consent from the participants involved in the study, it was stated that their data would not be used elsewhere.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Myocardial Reperfusion Injury, run by Tamer cebe 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 4 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: finished, as of the sponsor's last update on 18 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules. (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373549, which also lists 10 linked publications.
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 18 Apr 2024.