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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• A CCTA can be scheduled within 7 days after PCI

Locations
Other Locations
Sweden
Örebro University Hospital
RECRUITING
Örebro
Contact Information
Primary
Sara Cajander, MD
sara.cajander@oru.se
+46196021042
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2027-12
Participants
Target number of participants: 90
Treatments
Active_comparator: Vaccination arm
Influenza vaccine (Vaxigrip Tetra Sanofi Pasteur Europe).
Placebo_comparator: Placebo arm
Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
Sponsors
Collaborators: University of Cambridge, The Swedish Heart and Lung Association, Örebro University, Sweden
Leads: Region Örebro County

This content was sourced from clinicaltrials.gov