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Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study

This study is a follow-up to the IVORY trial, which looked at a medicine called IL-2 for people who had a heart attack. After a heart attack, blood vessels can become inflamed, which can worsen heart problems. The IVORY trial explored if a low dose of IL-2 could help by boosting protective immune cells to calm this inflammation. This new study is checking the long-term health of those IVORY participants. Researchers want to see if those who received IL-2 had fewer serious heart-related issues, like another heart attack or stroke, compared to those who received a dummy treatment. It helps us understand if this approach could lead to better outcomes for heart patients.

At a glance

Status
Recruiting
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrolment target
60
Start
01 Jun 2024
Estimated completion
11 Feb 2030
Acute Coronary Syndromes

What is this study about?

Heart attacks happen when the blood flow to your heart is blocked, often by fatty build-ups and inflammation in the blood vessels. This can damage the heart muscle. After a heart attack, this inflammation can continue, potentially leading to more problems in the future. The body's immune system plays a big role in both causing this inflammation and potentially helping to fix it.

Previous research has shown that people who've had heart attacks often have fewer 'regulatory T-cells'. These are special immune cells that help control inflammation. Scientists believe that increasing these protective cells could help reduce inflammation in blood vessels, prevent further blockages, and improve how the heart works after a heart attack. A medicine called aldesleukin, or IL-2, when given in small doses, can encourage the body to make more of these helpful regulatory T-cells.

The IVORY trial (a previous study) tested whether low-dose IL-2 could influence the immune system in this way. People who'd recently had a heart attack took part and were randomly given either IL-2 or a placebo (a dummy treatment, like a sugar pill), without knowing which they received. This new follow-up study, called IVORY-FINALE, is now tracking these same people to understand the long-term effects. Researchers will be carefully checking if those who received IL-2 in the original trial had fewer serious heart problems over time, like another heart attack, stroke, or needing further heart procedures, compared to those who received the placebo.

Key takeaways

  • This study is a follow-up to a previous trial (IVORY) about heart attacks.
  • It's checking long-term health outcomes for people who had a heart attack.
  • The focus is on whether a medicine called low-dose IL-2 helped reduce future heart problems.
  • Researchers are looking at information from medical records, not giving new treatments.
  • Results could help improve future treatments for heart attack patients.

Who may be eligible?

This study is specifically for people who have already finished taking part in the original IVORY clinical trial. To be included, you must have completed all the planned treatments in the IVORY trial, whether that was the active medicine (IL-2) or the dummy treatment (placebo).

Even if you are no longer alive, but you were part of the IVORY trial and gave permission for your medical records to be looked at, your information will still be included in this follow-up study. This helps researchers get a complete picture of the long-term effects across all participants.

You cannot be part of this follow-up study if you decided not to participate in future research when you were in the IVORY trial, or if you were withdrawn from the IVORY trial for any reason. If you decline to participate now, your data will not be included.

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. Did I previously take part in the IVORY trial?
  2. Did I complete all the treatments (IL-2 or placebo) in the IVORY trial?
  3. Did I agree to be contacted for future research during the IVORY trial?
  4. Do I agree to allow my medical records to be checked for this follow-up study?
Answer every question to see your result.

What does participation involve?

This study is a follow-up, which means most of the active 'taking part' was done during the original IVORY trial. For this new phase, you won't need to take any new medication or receive any new treatments directly for this study. The main part of your participation will involve the research team collecting information about your health from your medical records. This includes looking for any major heart-related events you might have experienced since the IVORY trial ended, such as another heart attack, stroke, or needing further heart operations. They will also look at other health events, such as hospital stays for heart reasons or other serious medical issues. There are no new study visits or assessments for you to attend.

Potential risks and benefits

Since this is a records-based follow-up study, there are no direct physical risks to you. Your medical information will be handled confidentially. The main benefit of participating is helping researchers understand if low-dose IL-2 could offer a new way to reduce long-term heart problems after a heart attack. This information could improve treatments for many people in the future. Remember, you have the right to withdraw your consent at any time, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting

Common questions

What is 'Acute Coronary Syndrome'?

This is the medical term for a sudden reduction of blood flow to the heart, which includes heart attacks and unstable angina.

What is IL-2?

IL-2 (interleukin-2) is a protein naturally made by your body. In this study, a special version of it was given in a low dose to try and boost protective immune cells.

What is a placebo?

A placebo is a dummy treatment, often a pill or injection that looks like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.

What does 'inflamation' mean in this study?

Here, inflammation refers to the body's natural response to injury or irritation in the blood vessels, but in heart conditions, it can become unhelpful and contribute to blockages.

Why is it important to follow up?

Following up helps researchers see if a treatment has long-term benefits or affects risks many years down the line, giving a more complete picture of its usefulness.

How to find out more

Official trial record

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 "Low-Dose IL-2 For The Reduction Of Vascular Inflammation In …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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