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RecruitingNAINTERVENTIONAL

IVUS Guided PCI in Patients With Chronic Kidney Disease

This study is for people with heart blockages and serious kidney disease. Normally, a procedure called PCI (angioplasty) uses a special dye to see the arteries, but this dye can sometimes damage already weak kidneys. This study explores a different approach. Doctors will use sound waves, known as intravascular ultrasound (IVUS), to guide the treatment without needing the kidney-damaging dye. The main goal is to see if using this sound wave method, often called "zero-contrast" angioplasty, can reduce the risk of further kidney problems after the heart procedure. Preventing this kidney damage is very important, as it can lead to more serious health issues.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
170
Start
08 Aug 2024
Estimated completion
04 Aug 2027

What is this study about?

When people have blocked arteries in their heart, a common treatment is called angioplasty (PCI). This procedure helps open up the blocked arteries. Usually, to guide this treatment, doctors inject a special liquid called a contrast dye, which helps them see the arteries clearly on X-rays.

However, for people who already have serious kidney disease, this contrast dye can sometimes cause further damage to their kidneys. This extra kidney damage, which doctors call contrast-induced nephropathy (CIN), can be serious. It can lead to longer hospital stays, the need for kidney dialysis, and other health complications. Right now, there isn't a specific way to treat this kidney damage once it happens, so preventing it is really important.

This study is looking at a new way to guide the angioplasty procedure, especially for people with serious kidney problems. Instead of using the contrast dye, doctors will use a method called intravascular ultrasound (IVUS). This technique uses sound waves to create detailed images of the arteries from the inside, similar to how an ultrasound scan works during pregnancy. Because IVUS doesn't need the contrast dye, the researchers hope it can help treat heart blockages without putting extra strain on the kidneys. The main aim is to see if using this "zero-contrast" IVUS-guided angioplasty can reduce the chance of kidney damage after the procedure.

Key takeaways

  • This study explores a safer way to treat heart blockages if you have serious kidney disease.
  • It uses sound waves (IVUS) instead of a special dye that can harm kidneys.
  • The goal is to prevent further kidney damage during the heart procedure.
  • It's for people needing angioplasty (PCI) who also have severe kidney problems.
  • Choosing to join is entirely voluntary and won't affect your regular care.

Who may be eligible?

To be considered for this study, you need to be over 18 years old and have a blocked artery in your heart that requires a procedure. You must also have serious kidney disease, which doctors will check through a specific kidney function test.

The doctors will also need to make sure that the IVUS method can be safely used for your particular heart blockage. Finally, you would need to be part of the UK social security system.

There are also some reasons why you wouldn't be able to join. For example, if you've already had a contrast dye injection recently, have a known allergy to the dye, or are already on permanent kidney dialysis, you wouldn't be eligible. Pregnant or breastfeeding patients, or those with very unstable blood pressure, also cannot take part. Your doctor will carefully review all of these points with you.

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.

  1. Are you over 18 years old?
  2. Do you need a procedure to open a blocked heart artery?
  3. Do you have serious, long-term kidney disease?
  4. Have you *not* had any special dye injected for a scan in the last 3 days?
  5. Are you *not* on permanent kidney dialysis?
  6. Are you *not* pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

This study doesn't mention specific details about extra visits, assessments, medication, or follow-up duration. However, if you join, you would undergo the standard angioplasty procedure for your heart blockage. The key difference would be the use of intravascular ultrasound (IVUS) to guide the procedure instead of the usual contrast dye. After the procedure, your kidney function would be closely monitored for 72 hours to see if using this new method helps prevent further kidney damage. Your care team would explain any additional checks during this short period.

Potential risks and benefits

Participating in this study might offer a potential benefit by reducing the risk of further kidney damage during your heart procedure, compared to the standard method using contrast dye. As with any medical procedure, there are always risks, but the study aims to use a guiding method that is already routinely used. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (2)

  • Romain GALLET
    Verified postcode
    Créteil, France· Not yet recruiting
  • Romain GALLET
    Verified postcode
    Créteil, France· Recruiting

Common questions

What is angioplasty (PCI)?

It's a procedure to open blocked heart arteries using a small balloon, often with a stent to keep the artery open.

What is 'contrast dye' and why is it usually used?

It's a special liquid injected into your body that helps doctors see your arteries clearly on X-rays during procedures.

Why is contrast dye a problem for people with kidney disease?

For people with serious kidney problems, the contrast dye can sometimes make their kidneys even weaker or cause new damage.

What is intravascular ultrasound (IVUS)?

It's a technique that uses sound waves to get detailed pictures of the inside of your heart arteries, without needing any dye.

Will using IVUS affect how well my heart blockage is treated?

IVUS is an established method for guiding heart artery procedures, and this study aims to show it's a safe and effective alternative for people with kidney issues.

How to find out more

Romain GALLET, Pr

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "IVUS Guided PCI in Patients With Chronic Kidney Disease…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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