Table of Contents
- Trial overview
- Who can participate
- What is being compared
- Trial phase and size
- Outcomes being measured
- What this means for patients
Trial overview
The available study is a Phase 3 interventional study in patients having isolated myocardial revascularization surgery with extracorporeal circulation.[1] It is authorised and planned to include 286 people.[1]
The trial is designed to compare the efficacy and safety of two cardioplegia strategies: Del Nido cardioplegia and Buckberg cardioplegia.[1] The main focus is how well each strategy protects the heart during surgery.[1]
Who can participate
The target population is patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation.[1] This is a type of heart bypass surgery done with a heart-lung machine.[1]
The trial data do not give more detailed inclusion or exclusion rules, so only this surgical group can be confirmed from the source.[1]
What is being compared
The study compares Del Nido cardioplegia with Buckberg cardioplegia.[1] Cardioplegia is a technique used during heart surgery to help protect the heart while the operation is being done.[1]
The brief summary says the goal is to compare these two strategies for myocardial protection, which means protection of the heart muscle.[1]
Trial phase and size
This study is in Phase 3, which is a later stage of research that usually looks at how well a treatment works and checks safety in a larger group.[1] The planned enrollment is 286 participants.[1]
Because the study is authorised, it has been approved to move forward according to the source data.[1]
Outcomes being measured
The main outcomes are markers of myocardial damage, especially CK and ultrasensitive Troponin T in the blood.[1] These are lab tests that help show whether the heart muscle has been injured after surgery.[1]
CK and Troponin T are checked daily during the first 5 postoperative days, and the peak value for each patient is recorded, usually around days 2 to 4 after surgery.[1]
Another main outcome is operative mortality, which means death within 30 days after the surgery or during the hospital stay if admission lasts longer than 30 postoperative days.[1]
What this means for patients
For patients, this trial is about finding the best way to protect the heart during bypass surgery.[1] The study does not focus on long-term treatment, but on short-term results right after surgery.[1]
The most important patient-centered results in this study are whether the heart shows less injury on blood tests and whether early death after surgery is reduced.[1] These results help researchers judge which cardioplegia strategy may be better for this surgical setting.[1]
