Using low-dose IL-2 to reduce vascular inflammation in heart attack patients
The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
Cambridge University Hospitals NHS Foundation Trust · NCT06427694
This study is trying to see if low-dose IL-2 can help heart attack patients by reducing inflammation and preventing serious heart problems after their initial treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (other) |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06427694 on ClinicalTrials.gov |
What this trial studies
This observational follow-up study aims to collect cardiovascular clinical outcome data from patients who completed the IVORY trial, which investigated the effects of low-dose IL-2 on acute coronary syndromes. The study will assess major adverse cardiovascular events (MACE) such as cardiovascular death and non-fatal myocardial infarction, as well as other adverse events related to cardiovascular health. By analyzing the impact of low-dose IL-2 on inflammation and immune response, the researchers hope to better understand its potential benefits in preventing further cardiovascular complications.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who completed the IVORY trial and received either low-dose IL-2 or placebo.
Not a fit: Patients who declined participation in the study or were withdrawn from the IVORY trial for any reason may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of vascular inflammation and reduced adverse cardiovascular outcomes in patients with acute coronary syndromes.
How similar studies have performed: Other studies have shown promise in using low-dose IL-2 to modulate immune responses, but this specific follow-up approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses Exclusion Criteria: * Patients who decline participation * Patients who did not consent to being contacted about future research * Patients who were withdrawn from the IVORY trial for any reason
Where this trial is running
Cambridge, Cambridgeshire
- Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Joseph Cheriyan, MBChB, FRCP — Cambridge University Hospitals NHS Foundation Trust
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Coronary Syndromes