A Phase 4 interventional study of Influenza vaccine and Placebo in Acute Myocardial Infarction, Cardiovascular Diseases and Inflammatory Response, sponsored by Region Örebro County. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Region Örebro County · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Influenza vaccine (Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02)
Biological: Influenza vaccine
Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
Biological: Placebo
Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
The 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.
Explorative endpoints
Differences in peripheral blood immune cell signatures measured by mass cytometry (CyTOF), and proteomics (O-link) will be assessed in a subset of patients with and without reduction in coronary inflammation, measured by perivascular adipose tissue density on CCTA . Single cell RNA sequencing (sRNAseq) and measurements of cytokine profiles after in-vitro stimulation of peripheral blood mononuclear cells (PBMCs) will be performed in a subgroup of patients
Time frame: 8 weeks follow up
Explorative endpoints
Exploratory proteomics by (O-link) from day 0 sampling will be performed in the whole study population to identify early biomarkers for prediction of residual inflammation.
Time frame: Baseline
Plan to share: No
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Region Örebro County