Evaluation of clinical impact of the type of cardioplegia used in the patient undergoing major cardiac surgery with extracorporeal circulation. CARDIO-HEART clinical trial.
This research, called the CARDIO-HEART trial, is investigating how different types of heart protection solutions affect patients undergoing major heart surgery. When someone has complex heart surgery, their heart needs to be temporarily stopped and protected. Doctors use special solutions called cardioplegia for this. This study is comparing two common solutions, Custodiol and Buckberg, to see which one leads to fewer problems such as heart attacks, kidney issues, or needing extra support after surgery. The aim is to understand which method gives patients the best chance of a good recovery within 90 days of their operation.
At a glance
What is this study about?
When you have major heart surgery, doctors often need to stop your heart for a short time to perform the operation safely. To protect your heart during this time, they use a special solution called 'cardioplegia'. This solution helps to keep your heart muscle healthy while it's not beating.
This particular study, the CARDIO-HEART trial, is like a careful comparison. It's looking at two different types of these heart protection solutions: one called Custodiol and another called Buckberg. Doctors already use both of these, but this study wants to find out if one of them leads to consistently better results for patients after surgery. They will be watching to see if patients who receive one solution have fewer complications like heart attacks, kidney problems, or other issues related to their heart's recovery in the 90 days after their operation. The goal is to make future heart surgeries even safer and more effective for everyone.
This type of study is called a 'Phase IV' trial. This means the treatments being looked at are already approved and in use. The study isn't testing brand new drugs, but rather comparing existing approaches to see which one works best in real-world use for patients having major heart surgery. Understanding these differences can help doctors make the best choices for their patients in the future.
Key takeaways
- Compares two existing heart protection solutions used in major heart surgery.
- Aims to find out which solution leads to better patient recovery and fewer problems.
- Involves adult patients having major heart surgery.
- Collects data from routine medical care; no extra tests just for the study.
- Results could improve future heart surgery practices.
Who may be eligible?
To be part of this study, you would need to be an adult, aged 18 or older. There is no upper age limit for taking part.
This study is open to both men and women who are scheduled to have a major heart operation. The most important factor is that you are undergoing a type of surgery that requires your heart to be temporarily stopped and protected using one of these special solutions.
Since this is about specific heart protection methods used during major heart surgery, you would only be eligible if your medical team determines that either of these solutions is appropriate for your planned procedure.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you scheduled for major heart surgery?
- Will your heart need to be temporarily stopped for the surgery?
- Are you comfortable with your treatment being part of a study comparing two standard solutions?
What does participation involve?
If you were to take part in this study, it would involve your medical team deciding which of the two heart protection solutions (Custodiol or Buckberg) to use during your planned major heart surgery. This choice would be made as part of the study design, but it will be a solution that your doctors would normally consider using for your operation anyway. You would receive the solution during your surgery, just as you would with standard care.
After your surgery, the research team would closely monitor your recovery for 90 days. This would involve collecting information from your routine hospital check-ups, blood tests, and scans that are already part of your normal care. They will be looking at things like how well your heart is recovering, if you have any complications like kidney problems or infections, and how quickly you get back on your feet. You wouldn't need extra hospital visits just for the study; all monitoring would happen during your standard medical care appointments.
Potential risks and benefits
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Common questions
What is 'cardioplegia'?
It's a special solution used by doctors to safely stop and protect your heart during major heart surgery.
Are the solutions being tested new and experimental?
No, both Custodiol and Buckberg solutions are already approved and widely used in heart surgery. This study is comparing them to see which works best.
Will I have extra tests or appointments if I join?
No, the study will gather information from your standard hospital check-ups and medical care that you'd have anyway after your surgery.
What kind of problems are they looking for after surgery?
They're looking for things like heart attacks, kidney problems, or needing extra support for your heart in the 90 days after your operation.
Who is funding this research?
The information provided does not specify the funding source, but it's a clinical trial comparing two existing medical practices.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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