Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis of non-ST-segment elevation myocardial infarction
A finalized coronary PCI
Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
Written informed consent
Disqualifiers
Has received influenza vaccination within 6 months
Other vaccination planned within 8 weeks (including covid-19 booster doses)
Severe allergy to eggs or previous allergic reaction to influenza vaccine
Cardiac surgery or staged PCI planned within 8 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
Influenza vaccine
Biological/VaccineInactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
Placebo
Biological/VaccineSodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Vaccination armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
Ascending aorta
Change from baseline in the perivascular adipose tissue density of the ascending aorta
Time frame
Between baseline and 8 weeks follow up.3
Interleukin 1 beta (IL-1β)
Difference in peripheral blood IL-1β concentrations
Time frame
Between baseline and 8 weeks follow up.4
Tumor necrosis factor alpha (TNF-α)
Difference in peripheral blood TNF-α concentrations
Time frame
Between baseline and 8 weeks follow up.Other outcomes
1
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 up2
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
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Örebro County
Lead sponsor
The Swedish Heart and Lung Association
Collaborator
Örebro University, Sweden
Collaborator
University of Cambridge
Collaborator
Aarhus University Hospital
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov