Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)

Official Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are: Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 90 participants

Interventions

• BIOLOGICAL: Influenza vaccine — Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
• BIOLOGICAL: Placebo — Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01

Primary Outcomes

• The right coronary artery (Between baseline and 8 weeks follow up.)

Secondary Outcomes

• The whole coronary tree (Between baseline and 8 weeks follow up.)
• Ascending aorta (Between baseline and 8 weeks follow up.)
• Interleukin 1 beta (IL-1β) (Between baseline and 8 weeks follow up.)
• Tumor necrosis factor alpha (TNF-α) (Between baseline and 8 weeks follow up.)
• Interleukin-2 receptor (IL-2r) (Between baseline and 8 weeks follow up.)

Trial Locations

• Aarhus University Hospital, Department of Cardiology, Aarhus, Denmark
• Örebro University Hospital, Örebro, Sweden
• Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

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