Follow-Up Study on Low-Dose Interleukin-2 Treatment Effects on Vascular Inflammation and Cardiovascular Outcomes in Acute Coronary Syndrome Patients

What this Trial Is About

This research investigates the potential of low-dose interleukin-2 IL2 treatment to reduce inflammation in blood vessels and lower adverse cardiovascular events in patients who have experienced acute coronary syndromes, such as heart attacks. It builds on a previous phase 2 trial called IVORY, which tested IL2s effect on immune cells and vessel inflammation. The follow-up study aims to collect clinical outcome data on major adverse cardiovascular events like heart attacks, strokes, and cardiovascular deaths in these patients. Participants in the original IVORY trial received either low-dose IL2 or a placebo, with IL2 dosing involving a loading dose followed by maintenance doses. The follow-up study observes these patients over time to compare outcomes between the IL2 and placebo groups. The study monitors adverse events including cardiovascular deaths, heart attacks, strokes, hospitalizations for heart-related issues, and other complications related to vascular disease over periods of 1, 2, and 5 years from initial dosing. During this follow-up, researchers collect data from medical records and monitor cardiovascular events and other health outcomes. They assess major adverse cardiovascular events such as cardiac death, non-fatal heart attacks, strokes, unplanned procedures, and hospital admissions. The study also tracks safety outcomes like deaths from any cause and arrhythmias. This observational study does not involve administering treatments but focuses on long-term monitoring of previous trial participants for up to 5 years after their initial treatment.

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