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New treatment option for Coronary Artery Disease
Official title Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells
ClinicalTrials.gov ID: NCT07610538
What this study is testing
What is Interleukin-2 (Aldesleukin)?
Interleukin-2 (Aldesleukin) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for coronary artery disease.
Also referred to as 1.5MIU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged over 18 years old
- Undergoing CABG surgery
You likely can't join if
- 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]
See the full eligibility criteria
- Aged over 18 years old
- Undergoing CABG surgery
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Cambridgeshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Cambridgeshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.