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Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study

This study aims to find simpler, less invasive ways to diagnose a heart condition called microvascular angina (CMD). Many people with chest pain don't have blockages in their main heart arteries, but they might have CMD, where the very small blood vessels in the heart don't work as they should, leading to chest pain and potential heart issues. Currently, diagnosing CMD involves an invasive procedure with some risks. This research will compare non-invasive CT and MRI scans with existing invasive tests to see if these safer methods can effectively identify CMD. Participants, already involved in another heart study, will undergo additional tests during their invasive heart procedure, followed by special MRI scans and further analysis of their CT images. The goal is to improve diagnosis and management of CMD, making it more comfortable and safer for patients.

At a glance

Status
Recruiting
Sponsor
University of Leicester
Enrolment target
20
Start
01 Nov 2023
Estimated completion
01 Dec 2026

What is this study about?

Imagine your heart is a house, and the main arteries are the big pipes bringing water in. Sometimes, people have chest pain even when these big pipes aren't blocked. This study focuses on the tiny, hair-like pipes (microvessels) inside the heart muscle. If these tiny pipes don't work properly, your heart might not get enough blood and oxygen, causing chest pain – this is called microvascular angina, or CMD.

Currently, to properly diagnose CMD, doctors usually need to perform an invasive test, which means putting a small tube into your blood vessels to look closely at your heart. While effective, this procedure carries some small risks and can be uncomfortable. This research wants to find out if we can diagnose CMD using less invasive methods like special MRI and CT scans, which are much gentler and safer for patients.

Researchers will recruit patients who are already part of another heart study and are having an invasive heart procedure for suspected angina. During this procedure, they'll have some extra tests done to check for CMD. They will then have a special MRI scan, which might involve some gentle exercise while in the scanner, and existing CT scans will be re-analysed. By comparing the results from these non-invasive scans with the detailed information from the invasive test, the study hopes to identify promising new ways to diagnose CMD without needing to undergo an invasive procedure, ultimately leading to better and safer care.

Key takeaways

  • New study exploring easier ways to diagnose microvascular angina.
  • Compares non-invasive scans (MRI, CT) with current invasive tests.
  • Aims to improve diagnosis and make it safer for patients.
  • Participants are already part of another heart research study.
  • May involve gentle exercise during an MRI scan.
  • You can withdraw at any time without affecting your care.

Who may be eligible?

To be considered for this study, you must already be taking part in a separate study called 'CMR versus CT-FFR in CAD'. You need to be at least 18 years old and be having an invasive heart procedure (angiography) because of chest pain.

It's important that you can understand the study information and are happy to give your consent to participate. You should also be able to follow all the study instructions and be able to do some exercise while in an MRI scanner. We'll also need your permission to inform your GP and specialist doctor about your involvement.

There are also reasons you wouldn't be able to join. For example, if you've had a heart attack in the last six months, suffer from severe claustrophobia, are pregnant or breastfeeding, or have certain other medical conditions. We'll check all these details carefully with you.

Quick self-check
  • Are you currently in the 'CMR versus CT-FFR in CAD' study?
  • Are you 18 years or older?
  • Are you having an invasive heart test (angiography) for chest pain?
  • Are you able to do some light exercise in an MRI scanner?
  • Are you not pregnant or breastfeeding?
  • Do you not have severe claustrophobia?

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

What does participation involve?

If you join this study, you will already be participating in a main research study called 'CMR versus CT-FFR in CAD'. During your planned invasive heart procedure (coronary angiography), additional tests will be performed to assess your heart's microvessels. Following this, you will have a special Heart MRI scan. This MRI will include new techniques and also an 'exercise MRI', where you might be asked to gently exercise, for example, on a cycle or stepping machine, while inside the scanner. Finally, researchers will look at your existing CT scan images in more detail. There are no additional hospital visits beyond your already scheduled appointments for the main study and your angiography. All these tests will help researchers compare different diagnostic methods.

Potential risks and benefits

Participating in this study might help researchers discover better, less invasive ways to diagnose microvascular angina, which could benefit future patients. The study uses tests that are already part of routine care or common research procedures. However, undergoing any medical procedure, including the invasive angiography and MRI, carries some potential risks (though these are generally small). For example, the invasive test has a small chance of complications, and some people feel claustrophobic during an MRI. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

  • Glenfield Hospital, University Hospitals of Leicester
    Leicester, United Kingdom· Recruiting

Common questions

What is microvascular angina?

It's chest pain caused by problems with the very tiny blood vessels in your heart, even if your main heart arteries are clear.

Why is this study important?

It aims to find safer, non-invasive ways to diagnose this condition, which currently often requires an invasive procedure.

Will I have to pay anything to take part?

No, all tests and procedures related to the study are covered by the research. You won't incur any costs.

What if I change my mind about participating?

You are free to withdraw from the study at any time without giving a reason, and it won't affect your medical care.

What does a 'non-invasive' test mean?

It means the test doesn't involve breaking your skin or going inside your body, like scans with a machine (like MRI or CT).

How to find out more

Ranjit Arnold

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 "Non-invasive Diagnosis of Coronary Microvascular Disease: Pi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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