ELLIPSE v1

  • Research type

    Research Study

  • Full title

    The effect of low-dose interleukin-2 on the immune landscape of human atherosclerotic plaques at single cell resolution

  • IRAS ID

    306797

  • Contact name

    Tian Zhao

  • Contact email

    tian.zhao@nhs.net

  • Sponsor organisation

    Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

  • Clinicaltrials.gov Identifier

    NCT05975554

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    Chest tightness during exertion (angina), heart attack, and stroke cause long-term disability and death for millions of patients worldwide every year. These conditions are caused by the narrowing of the blood vessels, known as atherosclerosis. This process is the result of fat build-up in the blood vessel wall, and the immune system's long-term over-activation called inflammation. After a heart attack or stroke, the resulting inflammation can worsen heart and brain damage, and speed up atherosclerosis progression. Frustratingly, despite knowing all this, we are currently unavailable to reduce inflammation in the blood vessels.

    In our previous study, we administered low-doses of an immune hormone call interleukin-2 to reduce inflammation in patients after a heart attack as measured in blood samples. To help us further develop this concept, we next need to find out if interleukin-2 is also decreasing inflammation in the narrowed blood vessels themselves.

    To achieve this, we plan to recruit 30 patients already scheduled to have a narrowing in their neck blood vessel surgically removed. These will be patients recently diagnosed with a stroke or mini-stroke. We will randomly assign half of the patients to interleukin-2 treatment (daily injection under the skin for 5 days given on the ward or in outpatients) before their surgery while the other half will receive normal clinical care. At the time of surgery, we will take the removed narrowed blood vessel (atherosclerosis) which is normally discarded, and examine it using state-of-the-art techniques to see if interleukin-2 is having the desired effects of reducing inflammation. The whole study will last around 2 weeks for each patient.

    This study will be an important step towards understanding the effect of interleukin-2 in patients immediately after a heart attack or stroke to improve the healing process, prevent further heart attacks and strokes, and therefore reduce disability and death.

  • REC name

    Wales REC 6

  • REC reference

    22/WA/0013

  • Date of REC Opinion

    25 Jan 2022

  • REC opinion

    Favourable Opinion