IVORY-FINALE
Research type
Research Study
Full title
The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes - Clinical Outcomes And Follow-up (IVORY-FINALE) Study
IRAS ID
339102
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart , due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.
The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function.
Interleukin-2 (IL-2), stimulates the production of Treg cells when given at low doses.
IVORY was conducted in patients diagnosed with narrowings/blockages in walls of blood vessels to the heart (Acute Coronary Syndrome (ACS)). 60 patients completed the trial and received either low dose IL-2 or placebo. The results have shown that extended treatment with low-dose IL2 was safe and reduced vascular inflammation in patients with ACS. As atherosclerosis and its complications are driven by inflammation we hypothesise that extended treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.
In this follow-up study we aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial. Clinical outcome data will include major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition data on adverse events such as all cause death, hospitalisations due to heart failure, amputations and revascularization due to peripheral vascular disease, or haemorrhagic stroke will be collected.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0059
Date of REC Opinion
9 Apr 2024
REC opinion
Further Information Favourable Opinion