RecruitingNAINTERVENTIONAL

Personalized Medicine Using Coronary Microvascular Function Measured in Patient With Percutaneous Coronary Intervention in Angina

This study, called 'Personalised Medicine for Angina', is for people who have chest pain, even after a heart procedure (like a stent). Sometimes, this pain is due to problems with the very small blood vessels in the heart, known as coronary microvascular disease. We're trying to find out if using a special measurement, called IMR (Index of Microcirculatory Resistance), can help doctors tailor treatment more effectively. The aim is to see if this personalised approach can reduce chest pain and improve quality of life for patients. The study will involve assessing the heart's blood vessels and, if needed, performing a procedure. We're looking for adults over 18 who have chest pain and fit certain other criteria.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

280

Start

31 Mar 2022

Estimated completion

01 Mar 2026

Coronary Microvascular Disease

What is this study about?

Imagine your heart has a very intricate network of tiny blood vessels, like tiny streams, that bring it oxygen and nutrients. Sometimes, these small vessels don't work as well as they should, even if the main, larger arteries are healthy or have been fixed. This condition is called coronary microvascular disease, and it can cause chest pain, known as angina.

Doctors are learning more about how important these tiny vessels are. In fact, problems with them can lead to more heart-related issues, even after a person has had a procedure to fix blockages in the larger heart arteries. This study wants to see if we can use a special measurement, called the IMR (Index of Microcirculatory Resistance), to understand these tiny vessels better. The IMR helps doctors get a clear picture of how well these small vessels are working.

The main idea of this study is to test if using this IMR measurement, along with another measurement called FFR (Fractional Flow Reserve) for the larger arteries, can help doctors create a more personal treatment plan. The goal is to find out if this tailored approach leads to less chest pain for people who have microvascular disease and have already had a procedure like a stent. This could mean a better quality of life for patients.

Key takeaways

The study aims to improve treatment for chest pain caused by tiny heart vessel problems.
It uses special measurements (IMR and FFR) to create a personalised treatment plan.
Participants will undergo an angiography procedure.
The goal is to reduce chest pain and improve quality of life.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be over 18 years old and regularly experience chest pain (angina). You must also be scheduled to have a procedure where doctors look at your heart's blood vessels through a thin tube called a catheter (this is called an invasive coronary angiography).

During this procedure, doctors will take specific measurements of your heart vessels. If you have any significant blockages, your doctor will decide whether a stent is needed. Importantly, you can't be pregnant or breastfeeding, have severe kidney problems, or have certain breathing or heart conditions that would make taking one of the study medications (adenosine) unsafe. If you're involved in another study or can't legally give your consent, you also won't be able to join.

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 over 18 years old?
Do you get chest pain (angina)?
Are you having a heart angiography procedure soon?
Are you not pregnant or breastfeeding?
Do you not have severe kidney disease or certain severe heart/breathing conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have an invasive coronary angiography procedure. During this, the doctors will measure both the FFR (Fractional Flow Reserve) in your larger heart vessels and the IMR (Index of Microcirculatory Resistance) in your tiny vessels. Based on these measurements, your care will be personalised. If a blockage needs fixing, a stent may be put in. If the FFR measurement shows no significant narrowing, a stent won't be placed for that specific issue.

After this, your treatment will be adapted based on your specific measurements. The study aims to see how this personalised approach affects your chest pain over time. The exact number of follow-up visits and the total duration isn't detailed, but typically, studies like this involve follow-up appointments to track your symptoms and well-being.

Potential risks and benefits

Taking part in this study could potentially lead to a more effective, personalised treatment plan for your chest pain, which might reduce your symptoms and improve your quality of life. However, as with any medical procedure, there are potential risks, including those associated with the angiography (such as bleeding, infection, or problems with the blood vessels) and the possibility of needing a stent. You will also be given a medication called adenosine during the measurements, which has its own set of potential side effects, though it's generally safe when given by trained professionals. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU Grenoble Alpes
Verified postcode
La Tronche, France· 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. It often feels like squeezing, pressure, heaviness, or tightness in the chest.

What is 'coronary microvascular disease'?

This is a condition where the very small blood vessels in your heart don't work properly, even if larger heart arteries are clear. It can cause chest pain.

What is an 'invasive coronary angiography'?

It's a procedure where doctors insert a thin tube (catheter) into a blood vessel, usually in your wrist or groin, and guide it to your heart. They inject dye to take X-rays and see your heart's blood vessels.

Will I receive new medication in this study?

The study focuses on personalising your treatment based on certain measurements. This might involve adjusting your current medications or providing different ones, guided by what the tests show is best for you.

What is IMR and FFR?

IMR (Index of Microcirculatory Resistance) and FFR (Fractional Flow Reserve) are measurements taken during an angiography. FFR checks for significant blockages in larger heart arteries, while IMR assesses how well the tiny blood vessels in your heart are working.

How to find out more

Gilles Barone Rochette

gbarone@chu-grenoble.fr +33476765172 Official trial record

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