Actively Recruiting
Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2026-05-28
24
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
R
Royal Papworth Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of low-dose interleukin-2 (ld-IL-2) treatment on tissue-resident regulatory T cells (Tregs) in patients who have had a myocardial infarction (heart attack). The study aims to compare the gene signatures related to activation, proliferation, and suppressive function of these Tregs in heart-related tissues versus peripheral blood, to better understand ld-IL-2's impact on tissue repair and inflammation after heart damage. This research focuses on patients undergoing coronary artery bypass graft (CABG) surgery and seeks to improve insights into immune responses in damaged heart tissues. Participants receive either ld-IL-2 at doses of 1.5 million international units (MIU) or 2.0 MIU daily for 5 consecutive days, followed by weekly doses if needed until their CABG surgery is completed. A control group receives standard care treatment without ld-IL-2. The ld-IL-2 is administered subcutaneously, and the study compares outcomes across these different treatment groups to assess the effects on immune cells within heart tissues and blood. Throughout the study, samples from heart tissues and peripheral blood are collected during surgery to analyze Treg gene signatures and other immune cell differences using advanced RNA sequencing methods. Researchers measure how ld-IL-2 influences immune cells related to tissue repair and anti-inflammatory responses. The study monitors participants from treatment through surgery and evaluates both primary and secondary immune-related outcomes to understand the therapy's impact on heart tissue healing and immune function.
CONDITIONS
Brief Title
Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 18 years old
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
You will not qualify if you...
- Critical left main stem coronary disease
- Severe valvular disease such as severe aortic stenosis
- Haemodynamic instability caused by arrhythmia requiring cardioversion during current admission
- Non-sustained ventricular tachycardia of more than 10 beats in the last 48 hours
- Autoimmune disease
- Any regular immunosuppressive treatment (inhaled or topical steroids allowed)
- Known active hepatic disease or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal
- Severe chronic kidney disease (eGFR less than 30 ml/min/1.73m2)
- Allergy or intolerance to aldesleukin
- Signs and symptoms of active infection
- History of HIV, hepatitis B or C
- Current malignancy requiring active treatment
- Vaccine within 4 weeks prior to screening
- Women who are pregnant, breastfeeding, or of child-bearing potential (unless postmenopausal or surgically sterile)
- Clinically relevant medical or surgical conditions that could increase risk in the opinion of the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the time of surgery (varies by participant)
Participants receive low-dose Interleukin-2 injections daily for 5 sequential days, with possible weekly doses until coronary artery bypass graft (CABG) surgery is completed, or they receive standard care if assigned to the control group.
Daily injections for 5 days, then weekly doses if needed until surgery
Duration - Day of surgery plus immediate recovery period
Participants undergo coronary artery bypass graft (CABG) surgery and immediate post-operative care.
1 surgical visit and immediate post-operative care
Trial Site Locations
Total: 2 locations
1
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
Actively Recruiting
2
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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