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

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

90 Participants
are divided into 2 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