Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
This study is investigating a new way to help your heart heal after a heart attack. We're looking at a drug called Interleukin-2, which we hope can boost your body's natural 'repair' cells. These special cells, called Tregs, are found in your tissues, including around your heart, and also in your blood. Previous research has mainly focused on Tregs in the blood. In this study, we want to understand if Interleukin-2 can make these repair cells more active and helpful directly within your heart and blood vessels. The goal is to see if this could lead to better healing and potentially reduce serious problems like heart failure after a heart attack. Participants will be those undergoing heart bypass surgery.
At a glance
What is this study about?
When you have a heart attack, part of your heart muscle can get damaged. Your body has amazing natural ways to try and fix itself, and part of this involves special cells called Tregs. These cells act like tiny peacekeepers, helping to calm down inflammation and encourage healing.
Although we've learned a lot about how these Tregs work in your blood, we don't fully understand what happens to them directly in your heart muscle and blood vessels after an injury like a heart attack, or how a drug might affect them there. This study aims to fill that gap. We're using a low dose of a medication called Interleukin-2 (also known as Aldesleukin), which we believe might encourage these repair cells in your heart to become more active and more effective at healing.
The main goal is to compare how these repair cells behave in the heart tissue of patients who receive Interleukin-2 compared to those who receive standard care. We'll also look at how these cells in your heart compare to those in your blood. Ultimately, by understanding how Interleukin-2 affects these cells in the damaged heart tissue, we hope to find new ways to help people recover better after a heart attack and potentially prevent long-term problems like heart failure.
Key takeaways
- This study explores a drug to help heart healing after a heart attack.
- It focuses on natural 'repair' cells (Tregs) in heart tissue.
- Participants will be adults undergoing heart bypass surgery.
- The goal is better recovery and reduced risk of heart failure.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults aged 18 or over who are having heart bypass surgery (CABG). If you are having this type of surgery, you might be a good fit.
However, there are certain health conditions or medications that would mean you couldn't take part. For example, if you have very severe issues with your main heart artery, severe valve problems, or an unstable heart rhythm. You also wouldn't be able to join if you have certain autoimmune diseases, are taking strong medicines to suppress your immune system (though inhaled or skin steroids are generally okay), or have serious kidney or liver disease.
We also can't include people with certain infections like HIV or hepatitis, recent vaccinations, or active cancer treatment. For women, you would need to be past menopause or have had surgery that stops periods; breastfeeding mothers cannot participate.
- Are you 18 years old or older?
- Are you scheduled for heart bypass surgery (CABG)?
- Do you have a severe heart condition other than a heart attack, like very severe valve disease?
- Do you have an autoimmune disease (like rheumatoid arthritis or lupus)?
- Are you taking strong immune-suppressing medicines (not including inhalers or creams)?
- Are you pregnant or breastfeeding, or could you become pregnant?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
The specific details of what your participation would involve aren't fully described here, but generally in studies like this, you would receive either the study drug (Interleukin-2) or standard care, potentially during or after your heart bypass surgery. Doctors would monitor you closely.
To understand how the drug affects your body, you would likely have regular blood tests and possibly tissue samples taken during your surgery (which would be explained beforehand). These samples would help researchers look at the repair cells in your heart and blood vessels. You would also have follow-up appointments and assessments over a period that would be explained to you before you agree to take part.
Potential risks and benefits
Locations (2)
- Royal Papworth Hospital NHS Foundation TrustCambridge, United Kingdom· Recruiting
- Addenbrooke's HospitalCambridge, United Kingdom· Recruiting
Common questions
What is a heart attack and why does it cause damage?
A heart attack happens when blood flow to part of your heart muscle is blocked, often by a blood clot. Without enough blood, the heart muscle doesn't get oxygen and can get damaged.
What are 'Tregs' and why are they important?
Tregs are special immune cells in your body that help control inflammation and promote healing. We hope they can help repair heart tissue after a heart attack.
What is Interleukin-2 (Aldesleukin)?
Interleukin-2 is a natural substance in your body, and Aldesleukin is a manufactured version. It's thought to encourage the growth and activity of certain immune cells, including those involved in repair.
What is heart bypass surgery (CABG)?
Heart bypass surgery is an operation to improve blood flow to your heart. It involves taking a healthy blood vessel from another part of your body and using it to 'bypass' a blocked artery in your heart.
Will taking part affect my regular heart care?
No, if you join this study, it will not affect the standard, high-quality medical care you would otherwise receive for your heart condition. This study is an addition to your usual treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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