Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery (NCT05603429) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery
Turkey (Türkiye)74 participantsStarted 2022-10-13
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Del Nido has beneficial effect for Endothelial function
Timeframe: through study completion, an average of 1 year
2
Del Nido cardioplegia solution has lesser oxidative effect comparing to blood cardioplegia
Timeframe: through study completion, an average of 1 year
3
SYNTAX effect (SYNergy between PCI{Percutaneous Coronary Intervention} with TAXUS and Cardiac. Surgery)
Timeframe: through study completion, an average of 1 year
4
LVMI effect
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT05603429
SponsorDr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital