RecruitingNAINTERVENTIONAL

Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

This study is for people who have ongoing chest pain, known as angina, even after trying several medications. Their pain comes from issues with the tiny blood vessels in their heart, not blockages in the main arteries. This condition is sometimes called microvascular angina. The study is investigating a new device called a Coronary Sinus Reducer. This small device is placed in a vein of the heart to help improve blood flow to areas that aren't getting enough. Researchers want to see if this device is acceptable to patients and effectively improves blood flow to the heart muscle, reducing their angina symptoms and improving their quality of life. This is a pilot study, meaning it's an initial step to see if the treatment is promising.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

17 Apr 2023

Estimated completion

06 Mar 2026

Refractory Angina Microvascular Angina Microvascular Coronary Artery Disease Coronary Disease Angina Pectoris

What is this study about?

Many people suffer from chest pain, called angina, when their heart doesn't get enough blood. Often, this is caused by blockages in the main heart arteries, which can be treated. However, some people have angina even though their main heart arteries are clear. In these cases, the problem often lies with the tiny blood vessels in the heart, a condition known as coronary microvascular dysfunction.

This type of angina can be difficult to treat, and current options are limited. This study is exploring a new treatment called a Coronary Sinus Reducer. This small, hourglass-shaped device is designed to be placed in a large vein called the coronary sinus, which collects blood from the heart muscle. By creating a gentle narrowing, the reducer is thought to help redistribute blood, improving flow to parts of the heart muscle that are currently starved of oxygen.

Researchers want to find out if this device is a suitable and effective way to help people with this kind of angina. The study will confirm if the procedure to implant the device is safe and if it genuinely helps improve blood flow to the heart, reduce pain, and improve overall well-being. This early-stage study will also look closely at how the device actually works within the heart's tiny blood vessels.

Key takeaways

New study for ongoing chest pain (angina) caused by small heart blood vessel issues.
Investigates a device called a Coronary Sinus Reducer to improve heart blood flow.
Compares the device to a 'sham' procedure to see if it truly helps.
Participation involves procedures, scans, and regular check-ups.
Aims to reduce pain, improve heart function, and quality of life.

Who may be eligible?

This study is looking for adults aged 18 or over who have had ongoing chest pain (angina) for at least three months. This pain should be bothering them regularly, even though they're already taking at least two different angina medications at the highest dose they can manage. Importantly, their angina must be due to issues with the very small blood vessels in their heart, not major blockages in the larger heart arteries.

You would not be able to join if you have significant blockages in your main heart arteries, have had a recent procedure like a stent within the last six months, or have had a heart attack. Other reasons for not being able to join include certain structural heart conditions, very low blood pressure in parts of your heart, severe kidney problems, very low blood count, or other serious lung conditions. Your heart's main vein (coronary sinus) also needs to be a certain size and shape for the device to fit.

If you're interested, you'd need to be happy to stick to your current medications during the study, be available for follow-up appointments, and understand what taking part would involve. You also need to be able to give your full agreement in writing to participate.

Quick self-check

Are you 18 years old or older?
Do you have ongoing chest pain (angina) despite taking at least two medications?
Have tests shown your chest pain is NOT from major blockages in your heart arteries?
Are you able to attend study appointments and follow instructions?
Do you have any severe kidney, lung, or other serious heart conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the Coronary Sinus Reducer or have a 'sham procedure'. The sham procedure involves going through the same steps as the actual device implantation, but without the device being placed, to help researchers understand if the benefits are truly from the device. Neither you nor your study doctor would know which group you are in. You would be asked to attend several appointments, which might include scans to check blood flow to your heart, tests to assess your heart's tiny blood vessels, and regular check-ups to monitor your symptoms and quality of life. You'd also be asked to continue with your current angina medications throughout the study. The total duration of your participation, including all follow-up, would be discussed with you by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment option if the Coronary Sinus Reducer proves effective in relieving your angina symptoms and improving your heart's blood flow. However, as with any medical procedure, there are potential risks, including those associated with the device implantation itself or the sham procedure. These risks would be fully explained to you before you decide to participate. Remember, you can choose to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

National Heart and Lung Institute (Brompton Campus), Imperial College London
London, United Kingdom· Recruiting

Common questions

What is angina?

Angina is a type of chest pain or discomfort that happens when your heart muscle doesn't get enough oxygen-rich blood.

What does 'non-obstructed coronary arteries' mean?

It means the main blood vessels supplying your heart aren't significantly blocked, but your chest pain is still caused by heart blood flow problems.

What is a 'Coronary Sinus Reducer'?

It's a small device placed in a large heart vein (the coronary sinus) to improve blood flow to the heart muscle, potentially easing angina.

What is a 'sham procedure'?

It's a procedure that looks like the real treatment but doesn't involve placing the device. This helps researchers fairly compare its effects.

Will I know if I get the actual device or the sham one?

No, neither you nor your study doctor will know which procedure you had. This is called 'double-blinded' and helps ensure fair study results.

How to find out more

Ranil de Silva, FRCP, PhD

r.desilva@imperial.ac.uk +44 2073518626 Official trial record

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