Low-dose i nterleukin 2 for the reduction of v ascular inflammati o n in acute corona ry syndromes (IVORY): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase II clinical trial.
| Autor: | Sriranjan R; Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK rfss2@cam.ac.uk., Zhao TX; Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK., Tarkin J; Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK., Hubsch A; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK., Helmy J; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK., Vamvaka E; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK., Jalaludeen N; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK., Bond S; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Hoole SP; Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge, UK., Knott P; Department of Clinical Immunology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Buckenham S; Department of Clinical Immunology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Warnes V; Department of Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Bird N; Department of Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Cheow H; Department of Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Templin H; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Cacciottolo P; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK., Rudd JHF; Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK., Mallat Z; Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK., Cheriyan J; Department of Medicine, Division of Experimental Medicine and Immunotherapeutics (EMIT), University of Cambridge, Cambridge, UK. |
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| Jazyk: | angličtina |
| Zdroj: | BMJ open [BMJ Open] 2022 Oct 07; Vol. 12 (10), pp. e062602. Date of Electronic Publication: 2022 Oct 07. |
| DOI: | 10.1136/bmjopen-2022-062602 |
| Abstrakt: | Introduction: Inflammation plays a critical role in the pathogenesis of atherosclerosis, the leading cause of ischaemic heart disease (IHD). Studies in preclinical models have demonstrated that an increase in regulatory T cells (Tregs), which have a potent immune modulatory action, led to a regression of atherosclerosis. The Low-dose InterLeukin 2 (IL-2) in patients with stable ischaemic heart disease and Acute Coronary Syndromes (LILACS) study, established the safety of low-dose IL-2 and its biological efficacy in IHD. The IVORY trial is designed to assess the effects of low-dose IL-2 on vascular inflammation in patients with acute coronary syndromes (ACS). Methods and Analysis: In this study, we hypothesise that low-dose IL-2 will reduce vascular inflammation in patients presenting with ACS. This is a double-blind, randomised, placebo-controlled, phase II clinical trial. Patients will be recruited across two centres, a district general hospital and a tertiary cardiac centre in Cambridge, UK. Sixty patients with ACS (unstable angina, non-ST elevation myocardial infarction or ST elevation myocardial infarction) with high-sensitivity C reactive protein (hsCRP) levels >2 mg/L will be randomised to receive either 1.5×10 6 IU of low-dose IL-2 or placebo (1:1). Dosing will commence within 14 days of admission. Dosing will comprise of an induction and a maintenance phase. 2-Deoxy-2-[fluorine-18] fluoro-D-glucose ( 18 F-FDG) positron emission tomography/CT (PET/CT) scans will be performed before and after dosing. The primary endpoint is the change in mean maximum target to background ratios (TBR Ethics and Dissemination: The Health Research Authority and Health and Care Research Wales, UK (19/YH/0171), approved the study. Written informed consent is required to participate in the trial. The results will be reported through peer-reviewed journals and conference presentations. Trial Registration Number: NCT04241601. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.) |
| Databáze: | MEDLINE |
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