RecruitingNAINTERVENTIONAL

Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study

This study is testing a new program called MICROFIT for people who experience chest pain due to a heart condition called microvascular coronary dysfunction. This condition means the tiny blood vessels in the heart don't work as well as they should. MICROFIT combines personalised high-intensity exercise and dietary advice. Before doing a bigger, main study, this research aims to see if MICROFIT is practical and acceptable for patients and medical staff. It also gathers early information on whether the program can help reduce symptoms like angina (chest pain). Participants will be divided into two groups: one receiving MICROFIT plus usual care, and the other receiving only usual care.

At a glance

Status

Recruiting

Phase

Sponsor

Royal United Hospitals Bath NHS Foundation Trust

Enrolment target

Start

12 Nov 2024

Estimated completion

01 Jan 2027

Microvascular Coronary Dysfunction Microvascular Angina Coronary Microvascular Dysfunction (CMD)

What is this study about?

Heart conditions can sometimes be due to problems with the large arteries that supply blood to your heart. However, for some people, the issue lies in the tiny blood vessels within the heart itself. This is called microvascular coronary dysfunction, and it can cause symptoms like chest pain, known as microvascular angina. It means these small vessels aren't expanding and contracting properly, affecting blood flow.

This study is looking at a new program called MICROFIT, which stands for Microvascular Coronary Rehabilitation For Improving Treatment. It's designed to be a personalised approach that combines specific high-intensity exercise with expert dietary advice. The main idea behind MICROFIT is to see if a focused program like this can help improve how well these tiny blood vessels work, ultimately reducing your symptoms and improving your overall well-being.

This particular study is a 'feasibility study'. This means it's an important first step to check if the MICROFIT program is practical and well-received before it's tested in a much larger group of people. Researchers want to make sure it's easy for people to join, stick with the program, and that both participants and staff find it acceptable. They will also collect early information on whether it helps with chest pain, which will be crucial for planning future, larger studies.

Key takeaways

This study evaluates a new exercise and diet program (MICROFIT) for chest pain caused by microvascular coronary dysfunction.
It's a 'feasibility study' to check if the program is practical and acceptable before a larger trial.
Participants will undergo various tests and either receive MICROFIT plus usual care, or usual care alone.
MICROFIT involves personalised high-intensity exercise and dietary advice over 24 weeks.
The study aims to gather initial data on whether MICROFIT can help reduce angina symptoms.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be 18 years or older and experiencing chest pain or similar symptoms. Your doctors would have confirmed that you have microvascular coronary dysfunction, meaning the smaller blood vessels in your heart aren't working as they should, even though your main heart arteries are clear.

There are certain health conditions that would mean you couldn't take part. This includes severe heart failure, severe problems with your heart valves, very high blood pressure that isn't controlled, or certain serious lung or kidney conditions. If you've had a recent stroke, blood clot, or are pregnant or breastfeeding, the study wouldn't be suitable for you.

It's also important that you're able to take part in exercise, don't have severe claustrophobia (which would affect some scans), and can fully understand the study information and instructions. The research team will carefully check all 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.

Are you 18 years old or older?
Do you experience chest pain, and has your doctor told you that you have microvascular coronary dysfunction?
Are you able to participate in physical exercise?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe heart failure or other serious heart/lung conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be placed into one of two groups by chance: either the MICROFIT program plus your usual medical care, or just your usual medical care. At the start and again after six months, everyone will have several health checks. These include detailed heart scans (like an echocardiogram and cardiac MRI), a special exercise test (CPET), body scans (DEXA), and blood tests. You'll also wear an activity tracker and keep a food diary for a week at both these times, and fill out questionnaires about your symptoms, mood, and quality of life.

If you're in the MICROFIT group, over 24 weeks you'll have one-on-one sessions with a personal trainer for high-intensity exercise and guidance for at-home workouts. You'll also meet with a dietitian for advice on improving your diet. You'll have two extra doctor's appointments to check your progress and an interview at the end to share your experiences. Everyone, in both groups, will get a summary of their results and progress at the end of the study. If you're in the usual care group, you'll also have a short 'taster' session to learn more about the MICROFIT exercise program.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as receiving specialised and close monitoring of your health, and for those in the MICROFIT group, access to a personalised exercise and diet program. However, there are also potential risks involved with medical tests, including radiation exposure from some scans (which is why pregnant women cannot take part), and the physical demands of high-intensity exercise. The research team will carefully explain all potential risks and benefits. Please remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (2)

Royal United Hospitals Bath NHS Foundation Trust
Verified postcode
Bath, United Kingdom· Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Verified postcode
Bristol, United Kingdom· Recruiting

Common questions

What is microvascular coronary dysfunction?

It's a heart condition where the small blood vessels in your heart don't work properly, leading to symptoms like chest pain, even if your main heart arteries are healthy.

What is high-intensity interval training (HIIT)?

It's an exercise strategy that involves short bursts of intense exercise followed by brief recovery periods.

Why is this study only looking at feasibility?

It's an important first step to ensure the program is practical, acceptable, and safe before running a larger study to definitively prove its effectiveness.

Will I know which group I'm in?

Yes, you will know if you are in the MICROFIT group or the usual care group. Participants are assigned by chance, like flipping a coin.

What happens after the study ends?

At the end, you'll receive a detailed debriefing on your investigation results and progress made during your participation.

How to find out more

Joanna Abramik

joanna.abramik1@nhs.net +44 1225 82109 Official trial record

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