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
Qualifiers
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
Treatments tested in this trial
- Influenza vaccine
- Placebo
Treatment groups
Sponsors and collaborators
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