All studies
RecruitingNAINTERVENTIONAL

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

This research, called ORBITA-MOON, is looking into why people with several narrowed heart arteries (multivessel coronary artery disease) experience chest pain, known as angina. It's a special type of study where neither the patients nor the researchers will know which artery is being tested at a given time. The main goal is to understand how each individual blockage in the heart's arteries contributes to someone's overall chest pain. To do this, doctors will temporarily and safely block one artery at a time in 60 patients. This helps them see which specific blockage causes symptoms. The hope is that this information will lead to better ways to treat angina and improve the quality of life for people with this condition.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Imperial College London
Enrolment target
60
Start
13 Jun 2024
Estimated completion
01 Apr 2027

What is this study about?

Imagine your heart is a house and the arteries are pipes that deliver water (blood and oxygen) to different rooms. If several pipes are narrowed, some rooms might not get enough water, causing problems. In people with angina, it can be tricky for doctors to know which specific narrowed pipe is causing the most trouble.

This study, ORBITA-MOON, is designed to help us understand this better. It focuses on people who have several narrowed heart arteries (what doctors call 'multivessel coronary artery disease') and experience chest pain, or angina. The research aims to find out which of these individual narrowed arteries is responsible for causing your symptoms. It's like checking each pipe individually to see which one, when it's temporarily blocked even more, truly makes a difference to the water flow.

To do this, a procedure called a percutaneous coronary intervention (PCI), often known as a 'stent procedure,' will be used in a very specific way. During this procedure, doctors will temporarily block each narrowed artery one by one and carefully watch for any symptoms you might experience. This helps them pinpoint which blockage is causing the angina. The information gathered from 60 patients will be incredibly valuable in improving how we treat angina in the future.

Key takeaways

  • This study aims to discover which specific heart artery blockages cause angina.
  • It involves temporarily testing individual narrowed arteries during a stent-like procedure.
  • The goal is to improve future treatments for angina.
  • You would need to have angina and multi-vessel heart artery disease to be considered.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have chest pain (angina) that doctors think could be helped by a procedure to open up your heart arteries (a PCI or stenting). You'd also need to have clear evidence from scans or other tests that you have significant narrowing in two or more of your heart arteries that are at least 2.5mm wide.

There are some reasons why you might not be able to take part. For example, if you've recently had a heart attack, if you've previously had major heart bypass surgery, if you have severe narrowing in a very important main heart artery, or if you have a completely blocked artery that can't be easily opened. Other reasons might include severe problems with your heart valves, very weak heart pump function, or if you can't have the PCI procedure or are allergic to certain medications used during the procedure, like antiplatelet drugs or adenosine. Pregnant individuals are also not able to participate.

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. Do I have ongoing chest pain (angina)?
  2. Do doctors think I might need a procedure to open my heart arteries (a stent)?
  3. Have scans or tests shown significant narrowings in two or more of my heart arteries?
  4. Have I recently had a heart attack or major heart bypass surgery?
  5. Do I have any severe heart valve problems or very weak heart function?
  6. Am I allergic to any medications used in heart procedures like anti-clotting drugs?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo a procedure where doctors treat your heart arteries. During this procedure (which is similar to putting in a stent), they will carefully assess each narrowed artery one by one. This involves temporarily and safely blocking individual narrowed arteries and monitoring any symptoms you might experience. This part of the study will involve careful observation to see how each blockage contributes to your angina.

After the procedure, you will likely have regular check-ups and assessments to monitor your health and symptoms. The full duration of your participation, including follow-up appointments, will be clearly explained by the study team. You will be given full details about any medications you need to take before, during, and after the procedure.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main benefit of this study is that it will help doctors better understand how different blockages in heart arteries cause angina. This knowledge could lead to improved treatments for people like you with similar conditions in the future. As for risks, any procedure involving your heart and arteries carries some risk, such as bleeding, infection, or complications related to the temporary blockage of an artery. The study team will explain all potential risks in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Essex Cardiothoracic Centre
    Verified postcode
    Basildon, United Kingdom· Recruiting
  • Royal Bournemouth Hospital
    Verified postcode
    Bournemouth, United Kingdom· Recruiting
  • Royal Sussex County Hospital
    Verified postcode
    Brighton, United Kingdom· Recruiting
  • Imperial College NHS Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Free London NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • St Georges University Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Nottingham City Hospital
    Verified postcode
    Nottingham, United Kingdom· Recruiting
  • Portsmouth Hospitals University NHS Trust
    Verified postcode
    Portsmouth, United Kingdom· Not yet recruiting
  • University Hospital Southampton
    Verified postcode
    Southampton, United Kingdom· Recruiting

Common questions

What is angina?

Angina is a type of chest pain or discomfort caused by reduced blood flow to the heart muscle. It often feels like squeezing, pressure, fullness, or pain in the middle of your chest.

What does 'multivessel coronary artery disease' mean?

This means you have blockages or narrowings in two or more of the important blood vessels that supply your heart (coronary arteries).

What is a PCI (Percutaneous Coronary Intervention)?

PCI, often called 'stenting,' is a procedure to open narrowed or blocked heart arteries. A small balloon is inflated to widen the artery, and often a small mesh tube (stent) is left in place to keep it open.

Will I know if I'm in the 'treatment' or 'placebo' group?

In this specific study, 'double-blinded' means neither you nor the doctors assessing you will know which specific artery is being tested at any given moment during the procedure. This is to ensure the results are as unbiased as possible.

How long will the study participation last?

The study team will provide you with a clear timeline for your involvement, including the procedure and any follow-up appointments. They can give you exact dates and durations.

How to find out more

Shayna Chotai, MBBS MRCP

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 "Multivessel Balloon Occlusion to Investigate Obstructive Cor…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.