Low-dose
Acute Coronary Syndrome
/ drug therapy
Atherosclerosis
C-Reactive Protein
/ metabolism
Clinical Trials, Phase II as Topic
Coronary Artery Disease
Double-Blind Method
Fluorodeoxyglucose F18
/ therapeutic use
Glucose
/ therapeutic use
Humans
Inflammation
/ drug therapy
Interleukin-2
/ therapeutic use
Myocardial Infarction
Myocardial Ischemia
/ drug therapy
Positron Emission Tomography Computed Tomography
Randomized Controlled Trials as Topic
Treatment Outcome
cardiology
cardiovascular imaging
clinical trials
immunology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
07 10 2022
07 10 2022
Historique:
entrez:
7
10
2022
pubmed:
8
10
2022
medline:
12
10
2022
Statut:
epublish
Résumé
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). 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 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. NCT04241601.
Identifiants
pubmed: 36207050
pii: bmjopen-2022-062602
doi: 10.1136/bmjopen-2022-062602
pmc: PMC9558794
doi:
Substances chimiques
Interleukin-2
0
Fluorodeoxyglucose F18
0Z5B2CJX4D
C-Reactive Protein
9007-41-4
Glucose
IY9XDZ35W2
Banques de données
ClinicalTrials.gov
['NCT04241601']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e062602Subventions
Organisme : British Heart Foundation
ID : CH/10/001/27642
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N028015/1
Pays : United Kingdom
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Department of Health
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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