NCT06336317

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myocardial Infarction
• Cardiovascular Diseases
• Inflammatory Response

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccine	Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
BIOLOGICAL	Placebo	Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01

Timeline

• Start date: 2024-04-24
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-03-28
• Last updated: 2026-04-07

Locations

3 sites across 3 countries: Denmark, Sweden, United Kingdom