Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
Cambridge University Hospitals NHS Foundation Trust
24 participants
Mar 31, 2026
INTERVENTIONAL
Conditions
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 Criteria2
- Aged over 18 years old
- Undergoing CABG surgery
Exclusion Criteria16
- 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
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Interventions
5 sequential days of treatment (1.5MIU/day subcutaneously) and, if needed, 1.5MIU/week doses until CABG surgery completed
Standard care for patients with coronary artery disease undergoing CABG surgery
5 sequential days of treatment (2.0MIU/day subcutaneously) and, if needed, 2.0MIU/week doses until CABG surgery completed
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07610538