Not yet recruitingNAINTERVENTIONAL

Feasibility of a Cardiac Rehabilitation Program for CTO Patients Before PCI Treatment

This study is exploring a 'pre-hab' programme for people in the UK with a specific type of blocked heart artery, called Chronic Total Occlusion (CTO). This blockage means blood flow to the heart is reduced. Usually, a procedure called PCI is planned to open these arteries. This study wants to see if doing a special health and exercise programme for six months beforehand can make people feel better and improve their heart health. Researchers will check if this programme helps people become fitter and if it might even mean fewer people need the PCI procedure. If PCI is still needed, they'll check improvements afterwards. The study helps understand if 'pre-hab' is a good step for CTO patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Luiz Ybarra

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Oct 2026

Chronic Total Occlusion (CTO)

What is this study about?

This study is about a problem called Chronic Total Occlusion (CTO). This means that a major blood vessel supplying your heart has been completely blocked for a long time. This can cause symptoms like chest pain or shortness of breath because your heart isn't getting enough blood. Usually, doctors would consider a procedure called Percutaneous Coronary Intervention (PCI) to unblock the artery and improve blood flow. However, this study is trying a different approach first.

This study will look at whether a special programme, sometimes called 'pre-hab' (short for pre-habilitation), can help people with CTO before they have their PCI procedure. Think of 'pre-hab' like getting fit before a big event. It's a structured exercise and health programme designed to improve your overall health and fitness. The main idea is to see if joining this programme for six months can make you feel better and improve your heart health so much that you become fitter and stronger.

The researchers want to answer two main questions: Can this 'pre-hab' programme actually make people with CTO more active and improve their health before a PCI? And, importantly, could being healthier from the programme mean that some people might no longer need the PCI procedure, or perhaps they could delay it? This study aims to gather important information to see if this 'pre-hab' approach is a good, helpful step for patients with CTO.

Key takeaways

This study explores a health and exercise plan to improve heart health.
It's for people with a long-term blocked heart artery (CTO).
The goal is to see if fitness improvements can help before a PCI procedure.
It might reduce or delay the need for the PCI procedure.
Participants will follow a 6-month supervised programme and have regular check-ups.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have at least one major heart artery that has been completely blocked for a long time (this is called a Chronic Total Occlusion, or CTO). To be considered, you also need to be experiencing symptoms like chest pain (angina) and tests must show that your heart muscle isn't getting enough blood, or that parts of it could be saved.

However, there are reasons why you might not be able to join. For example, if you can't or don't want to take part in the exercise programme, or if you've already been part of a similar heart rehabilitation programme in the last year, you wouldn't be eligible. Also, if you have other serious health problems that mean you're not expected to live for at least another year, or if your heart condition is very severe or unstable, you wouldn't be able to participate.

Other reasons you might not be able to join include if you're pregnant, have recently had a heart attack (in the last two months), or have certain severe heart valve problems that would likely need surgery soon. You also need to be able to understand and complete the questionnaires used in the study.

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 have a heart artery that's been completely blocked for a while (CTO)?
Are you experiencing chest pain or other heart-related symptoms?
Are you able and willing to take part in an exercise rehabilitation programme?
Have you not participated in a similar heart rehab programme in the last year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves several steps over about a year. Firstly, you'll have an initial check-up. This will include a physical examination, a review of your current medications, blood tests, and you'll fill out some questionnaires about your quality of life and how you're feeling.

After this, you'll join a 6-month special health and exercise programme designed for people with heart conditions. This is the 'pre-hab' part of the study. After these six months, you'll have another set of assessments. The doctors will check your fitness again and see how much you've improved. Based on these results, they will decide if the procedure to unblock your artery (PCI) is still needed.

If the PCI procedure is still recommended, you'll have it, and then your fitness will be checked again one month later. If, after the 6-month programme, the PCI is no longer considered necessary, you'll continue to be in contact with the rehabilitation team virtually for another five months. Throughout the study, the team will be checking on your health and progress.

Potential risks and benefits

Taking part in this study could potentially offer you several benefits. The main one is improving your heart health and overall fitness through a structured exercise programme before any planned procedure. This might make you feel better, improve your quality of life, and potentially reduce the need for a PCI procedure. As with any exercise programme, there are small risks, such as muscle soreness or, in rare cases, more serious heart-related events, especially if you have a heart condition. However, the programme will be medically supervised, and your health will be closely monitored. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Hospital
Verified postcode
London, Canada

Common questions

What is 'pre-hab'?

'Pre-hab' is a special health and exercise programme designed to improve your fitness and overall health before a medical procedure, like a heart operation.

What is a Chronic Total Occlusion (CTO)?

A CTO means one of the main blood vessels supplying your heart has been completely blocked for a long time, reducing blood flow to your heart muscle.

What is PCI?

PCI stands for Percutaneous Coronary Intervention. It's a procedure doctors use to unblock arteries and restore blood flow to the heart, often using a small balloon and a stent.

Will I have to exercise a lot?

The study involves a structured exercise and health programme over six months, but it will be tailored to your abilities and carefully monitored by medical professionals.

What if I feel worse during the study?

Your health will be closely monitored throughout the study. If you feel unwell or have concerns, you should tell the study team immediately. You can also withdraw from the study at any time.

How to find out more

Luiz F Ybarra, MD PhD MBA FRCPC

luiz.ybarra@lhsc.on.ca 519-685-8500 Official trial record

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