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.
Following informed consent patients are randomized in a 1:1 fashion to influenza vaccination or placebo up to 7 days following PCI. Blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion. Patients will undergo CTCA at baseline (≤ 7 days of an AMI) and 8 weeks after PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
Aarhus University Hospital, Department of Cardiology
Aarhus, Denmark
RECRUITINGÖrebro University Hospital
Örebro, Sweden
RECRUITINGCambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
RECRUITINGThe right coronary artery
Primary endpoint definition is a difference in pericoronary adipose tissue density (perivascular fat attenuation index) around the right coronary artery (RCA) measured by repeated CCTA imaging
Time frame: Between baseline and 8 weeks follow up.
The whole coronary tree
Change from baseline in the average pericoronary adipose tissue density of the whole coronary tree (main epicardial arteries ≥2mm).
Time frame: Between baseline and 8 weeks follow up.
Ascending aorta
Change from baseline in the perivascular adipose tissue density of the ascending aorta
Time frame: Between baseline and 8 weeks follow up.
Interleukin 1 beta (IL-1β)
Difference in peripheral blood IL-1β concentrations
Time frame: Between baseline and 8 weeks follow up.
Tumor necrosis factor alpha (TNF-α)
Difference in peripheral blood TNF-α concentrations
Time frame: Between baseline and 8 weeks follow up.
Interleukin-2 receptor (IL-2r)
Difference in peripheral blood IL-2r concentrations
Time frame: Between baseline and 8 weeks follow up.
Interleukin Interleukin-6 (IL-6 )
Difference in peripheral blood IL-6 concentrations
Time frame: Between baseline and 8 weeks follow up.
Ferritin
Difference in peripheral blood ferritin concentrations
Time frame: Between baseline and 8 weeks follow up.
Troponin-I
Differences in peripheral blood troponin-I concentrations between study groups
Time frame: At 8 weeks follow up.
N-terminal pro-B-type natriuretic peptide
Differences in peripheral blood N-terminal pro-B-type natriuretic peptide concentrations between study groups
Time frame: At 8 weeks follow up.
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