Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Every year, many people in the UK have a heart procedure where stents are put into narrowed blood vessels. While usually safe, some patients with very diseased hearts or weakened heart muscles face a higher risk of serious problems, like their heart struggling during the procedure. This study called CHIP-BCIS3 is investigating a small heart pump that can be placed in the heart during the stent procedure to help support it. This pump is put into the heart through a blood vessel in the leg. The goal is to find out if using this pump helps these high-risk patients have safer procedures and reduces serious issues. The study also wants to understand if the benefits of the pump are worth its cost.
At a glance
What is this study about?
Heart conditions like angina or having a heart attack often mean needing a procedure called a coronary stent. This is where doctors use a tiny balloon to open up a blocked blood vessel in your heart, then place a small mesh tube called a stent to keep it open. Over 100,000 of these procedures happen in the UK every year, and they are usually very safe.
However, for some people, especially those with very diseased heart arteries or already weakened hearts, there's a higher chance of complications during the stent procedure. This can include their heart struggling or even failing, which is very serious and can lead to major damage or even be life-threatening. Doctors are always looking for ways to make these procedures safer for everyone.
This study is looking at a new device: a small heart pump. It's called a 'left ventricular unloading device' and it's designed to help support your heart if it's at risk of struggling during the stent procedure. The pump is put into your main heart pumping chamber through a blood vessel in your leg. It helps your heart muscle pump blood, and it's removed once the procedure is over or your heart is stable enough on its own. While this pump shows promise, it also has some potential downsides like a risk of bleeding or damaging blood vessels, and it's quite expensive. This study aims to find out if using this pump really helps high-risk patients and if it's a cost-effective treatment option.
Key takeaways
- The study assesses a new heart pump during complex stent procedures.
- It targets patients at high risk of complications during heart stenting.
- The goal is to see if the pump makes procedures safer and is cost-effective.
- Participation involves either receiving the pump or standard care, decided by chance.
- Potential risks include bleeding or blood vessel damage from the pump itself.
Who may be eligible?
To join this study, people need to meet certain health requirements. Generally, you would be considered if you have widespread disease in the blood vessels supplying your heart and your main heart pumping chamber (the left ventricle) is already quite weak. This is usually due to a low pumping ability. You would also need to be having a complex stent procedure.
The complex stent procedure means things like having a blockage in one of the main arteries (left main artery) that supplies your heart, or needing a special treatment to remove hard calcium from your arteries, or having a completely blocked blood vessel that doctors plan to treat using a specific advanced technique.
However, you could not participate if you are currently in a very serious heart condition called cardiogenic shock (where your heart can't pump enough blood for your body's needs) or if you've recently had a severe heart attack. You also can't join if you can't give your informed consent to take part, or if you're already in another study that might affect the results of this one.
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.
- Do I have extensive blockages in the blood vessels supplying my heart?
- Is my heart's main pumping chamber (left ventricle) significantly weakened?
- Am I scheduled for a complex stent procedure that meets certain criteria (like a tricky main artery blockage or needing special calcium removal)?
- Am I currently in a very serious heart situation like cardiogenic shock or have I just had a major heart attack?
- Am I able to understand information and give consent to participate?
What does participation involve?
If you take part in this study, the doctors might decide that you will either receive the special heart pump during your stent procedure or just have the standard stent procedure without the pump. This decision is made by chance, like flipping a coin. You will have regular checks and assessments during your hospital stay and for a certain period afterwards to see how you are recovering and if the treatment was successful. This follow-up will involve visits to the clinic and possibly some tests. The total time you would be involved in the study would depend on how long doctors need to monitor your recovery and health after your heart procedure.
Potential risks and benefits
Locations (1)
- Guy's and St Thomas' NHS Foundation TrustVerified postcodeLondon, United Kingdom
Common questions
What is a 'coronary stent procedure'?
It's a common operation where doctors use a small balloon to open a narrowed heart artery and then place a tiny mesh tube (stent) to keep it open, improving blood flow to your heart.
What is a 'left ventricular unloading device'?
It's a small heart pump inserted through a leg blood vessel into your heart's main pumping chamber. It helps your heart pump blood during complex heart procedures.
Why is this study needed?
This study aims to find out if this support pump makes high-risk stent procedures safer for patients and if it's a good use of healthcare resources, as there isn't enough clear evidence yet.
Will I definitely get the heart pump if I join?
No, whether you get the pump or standard care is decided by chance, like drawing lots. This helps researchers compare the treatments fairly.
Is the heart pump removed?
Yes, the heart pump is typically removed at the end of the stent procedure or when your heart is stable enough to pump on its own.
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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