RecruitingNAINTERVENTIONAL

Heart Attack Blood Oxygen Therapy Trial

This study is investigating a new treatment called 'supersaturated oxygen therapy' for people who have recently had a heart attack. A heart attack happens when a main blood vessel supplying the heart is blocked, damaging the heart muscle. After doctors unblock the artery with a stent, this new treatment aims to give the heart extra oxygen for one hour. This could help the heart muscle heal better and reduce the risk of heart failure. Unlike previous approaches, this study will deliver the oxygen therapy through the wrist, which is now a common way to treat heart attacks. The study will look at how safe and practical this treatment is, and if it shows any signs of helping patients.

At a glance

Status

Recruiting

Phase

Sponsor

NHS National Waiting Times Centre Board

Enrolment target

Start

25 Oct 2024

Estimated completion

01 Nov 2038

Myocardial Infarct Remodeling, Left Ventricle

What is this study about?

Heart attacks are a serious medical emergency, where a blockage in a heart artery causes damage to the heart muscle. This damage can sometimes lead to heart failure, a condition where the heart can't pump blood as well as it should. For many years, treatments for heart attacks have focused on unblocking the artery as quickly as possible, usually by inserting a small tube and balloon (a 'stent') to open it up.

Despite new ways to open blocked arteries, we haven't found many new medicines to specifically help prevent heart failure after a heart attack. This study is exploring a new approach called 'supersaturated oxygen therapy'. This treatment involves giving extra oxygen directly to the heart muscle after the blocked artery has been opened. The idea is that more oxygen might help the damaged heart tissue recover better and potentially reduce long-term problems.

This study is important because it's testing a new way to deliver this oxygen therapy. In the past, this kind of treatment might have been given through a blood vessel in the groin, which isn't always comfortable. Now, most heart attack procedures are done through the wrist. So, this study will see if giving the extra oxygen through the wrist is safe, practical, and shows any early signs of benefit for patients. It will also help decide if a much bigger study is needed in the future.

Key takeaways

Aims to improve heart recovery after a heart attack.
Tests a new oxygen therapy delivered through the wrist.
Compares the oxygen therapy to a dummy procedure.
Includes MRI scans and questionnaires to track heart health.
Helps decide if a larger study is needed.
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 at least 18 years old and have had a recent heart attack that affected the main front part of your heart. It's important that you received treatment to unblock your artery within six hours of your symptoms starting, and that this procedure was successful using the blood vessel in your wrist.

There are certain reasons why this study might not be right for you. For example, if you have other serious heart problems like severe valve issues, or if you are pregnant. If you have very low blood levels or a bleeding disorder, or if you've had major surgery recently, you might also not be able to join. Additionally, if you can't have an MRI scan (for example, due to severe claustrophobia or certain metal implants), you wouldn't be able to participate. The study team will check all these details carefully with you.

Quick self-check

Are you 18 years old or older?
Did you have a heart attack affecting the main front part of your heart?
Was your heart artery unblocked through your wrist within 6 hours of symptoms?
Do you feel comfortable having MRI scans?
Do you not have other serious heart problems or conditions like pregnancy?

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

What does participation involve?

If you are invited to join this study and agree, it would involve a few steps. Firstly, after your heart attack treatment, you'll be asked if you'd like to take part. During the study, you would either receive the supersaturated oxygen therapy or a 'dummy' procedure, which is designed to feel similar but doesn't deliver oxygen. This treatment (or dummy procedure) lasts for about one hour.

As part of the study, we would also take some blood samples and conduct a special heart scan called an MRI, usually within 2 to 5 days after your heart attack, and again about 3 months later. You would also be asked to complete some health questionnaires to understand how you are feeling. All of this helps us gather important information about the treatment's safety and any potential benefits. The total duration of active participation, including follow-up scans, would be about 3 months, though we might ask for your permission to track your health records for longer.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping your heart recover better after a heart attack, although this is not guaranteed, as it’s a research study. Potential risks are generally low, as the oxygen therapy is already approved for use in other settings, and the procedures involved are similar to standard heart care. As with any medical procedure, there's a small risk of discomfort or bruising from blood samples or the wrist procedure. You will be closely monitored by medical staff throughout. You are free to withdraw from the study at any time without giving a reason, and this will not affect your standard medical care.

Locations (1)

Golden Jubilee National Hospital
Clydebank, United Kingdom· Recruiting

Common questions

What is a 'dummy procedure'?

A 'dummy procedure' (also called a sham or placebo) is like a pretend treatment. It's done to compare against the real treatment, so we can tell if any changes are due to the treatment itself or other factors. For you, it would feel similar to the actual treatment, but without the extra oxygen.

Why is it important to do this study through the wrist?

Most heart attack treatments now use the wrist. If this oxygen therapy works and can be given through the wrist, it would be much easier to offer to more patients as part of their standard care.

How long does the supersaturated oxygen therapy last?

The treatment or dummy procedure itself lasts for about one hour.

Will I know if I'm getting the real treatment or the dummy procedure?

No, neither you nor the doctors treating you will know which treatment you are receiving. This is called 'blinding' and helps ensure the study results are as fair and accurate as possible.

What is unique about this study?

This study is unique because it's testing a new way to deliver supersaturated oxygen therapy through the wrist, using a dummy procedure for comparison, and carefully blinding patients and staff to ensure fair results.

How to find out more

Colin Berry, BSc MBChB PhD

colin.berry@glasgow.ac.uk 441419515180 Official trial record

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