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

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05603429

Acronym / sponsor ID

HNEAH-KAEK 2022/43-3507

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

Study type

Observational

Recruitment status

Completed

Enrolment

74 participants (actual)

Lead sponsor

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalUniversity, hospital or other

Study start

13 Oct 2022 (actual)

Primary completion

25 Jul 2023 (actual)

Study completion

8 Aug 2023 (actual)

First posted

2 Nov 2022 (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.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

2 Weeks

Number of arms

4

Who may qualify

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Patients diagnosed with coronary artery disease and aortic valve stenosis irrespectively

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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

2. 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

3. 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)

4. 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)

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 14 Aug 2023.
• Background: PubMed 28863040Li 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.
• Background: PubMed 20656301O'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.
• Background: PubMed 29246552Ad 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.
• Results publication: PubMed 33118734Orak 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.
• Individual participant dataSharing planned: Undecided

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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.

1 site in 1 country: see every site and its status.