Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
NCT07610538
Summary
The primary goals of this study are to compare the differences in tissue-resident Treg gene signature for activation, proliferation, and suppressive function using single-cell/-nucleus RNA sequencing in patients treated with ld-IL-2 compared to control grouped by individual tissue beds from in and around the heart. Additionally, tissue-resident Tregs will be compared to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2 on the two compartments.
Eligibility
Inclusion Criteria: * Aged over 18 years old * Undergoing CABG surgery Exclusion Criteria: * Critical left main stem coronary disease * Severe valvular disease (for example 'severe' aortic stenosis as classified on echocardiogram report) * Haemodynamic instability caused by arrhythmia requiring cardioversion in the current admission * Non-sustained ventricular tachycardia of \>10 beats in the last 48 hours * Autoimmune disease * Any regular immunosuppressive treatment \[Inhaled or topical steroids are permissible\] * Known active hepatic disease or alanine aminotransferase (ALT) \> 3xULN * Severe chronic kidney disease (defined as eGFR \< 30 ml/min/1.73m2) * Allergy or intolerance to aldesleukin * Signs and symptoms of active infection * History of human immunodeficiency virus (HIV), hepatitis B or C * Current malignancy requiring active treatment * Vaccine within 4 weeks prior to screening * Women of child-bearing potential and pregnancy (women must be either postmenopausal (defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile (e.g. age appropriate (\>55 years old), history of vasomotor symptoms) or having documented hysterectomy and/or bilateral oophorectomy) * Women who are breast-feeding * Clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
Conditions4
Interventions1
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NCT07610538