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Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells

RECRUITINGN/ASponsored by Cambridge University Hospitals NHS Foundation Trust
Actively Recruiting
PhaseN/A
SponsorCambridge University Hospitals NHS Foundation Trust
Started2026-03-31
Est. completion2028-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

CABGCoronary Artery DiseaseHeart DiseaseMyocardial Infarction (MI)

Interventions1

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