Summary of Methods from the Provided Text:
This text details the methodology of the IVORY and IVORY-FINALE studies, focusing on patient randomization, imaging protocols, immunophenotyping, and outcome measures. Here’s a breakdown:
1. Patient Randomization & Allocation:
* Patients were randomly assigned to either a placebo group (5% dextrose) or a treatment group (1.5 x 106 IU of IL-2) in a 1:1 ratio.
* Randomization was performed using a web-based request (www.sealedenvelope.com) with permutated block randomization (block sizes of 2, 4, and 6).
* Stratification was based on ST-segment elevation status.
2. Imaging Protocol ([[[[18F]FDG PET-CT):
* patients underwent[[[[18F]FDG PET-CT scans of the ascending aorta and carotid arteries before and after treatment.
* Established and reproducible methods were used, referencing specific publications ([20, 22]).
* patients were fasted for 6 hours before scans.
* Approximately 240 MBq of[[[[18F]FDG was administered intravenously 90 minutes before imaging.
* The ascending aorta was imaged first, followed by the carotid arteries (left and right). These areas were chosen due to their validated reproducibility in atherosclerosis trials ([20, 21]).
* TBRmax Calculation: Arterial[[[[18F]FDG TBRmax (Target-to-Background Ratio) was calculated as the mean arterial maximum standardized uptake value (SUVmax) divided by the average of venous SUVmean from internal jugular veins (for carotids) and the superior vena cava (for the ascending aorta).
* Standardized protocols were used for uptake times, injected dose, and reconstruction parameters. A phantom study was conducted for quantification accuracy.
3.Immunophenotyping:
* Blood samples were taken at the start and end of the induction phase, at alternate visits during the maintenance phase, and approximately 1 week after treatment cessation.
* Flow cytometry (FACS) was used to analyze immune cell populations.
* A detailed list of antibodies used (with catalogue numbers and clones) is provided, including those targeting CD196, CD25, CD194, CD197, CD185, CD4, CD45RA, CD183, CD3, CD127, CD8, and CD279.
4. Outcome Assessment:
* Patients completing the IVORY trial were invited to enroll in the IVORY-FINALE study.
* Clinical outcomes were collected via telephone questionnaire and verified with medical records, reviewed by an adjudication committee.
* Primary Outcome: Absolute difference in mean TBRmax of the index vessel (most inflamed vessel on pre-treatment scans) at the end of treatment between the IL-2 and placebo groups.
* Secondary Outcomes: Difference in mean TBRmax for more inflamed areas (active segments).
In essence, the study uses a rigorous methodology involving randomized controlled trials, advanced imaging techniques, detailed immunophenotyping, and careful