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NCT Number: NCT06336317

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

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.

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Infections Inflammatory Response Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Department of Cardiology, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Coronary stent involving the proximal RCA
  • Suspicion of febrile illness or acute, ongoing infection
  • Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol
  • Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response
  • Inability to provide informed consent
  • Previous randomization in the ELIMINATE trial
  • Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
  • Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment [eGFR <30 mL/min/1.73 m2])
  • Atrial fibrillation
  • Uncontrolled chronic inflammatory disease
  • Unable to comply with protocol requirements

Treatment and study plan

influenza vaccine

Biological

Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02

Placebo

Biological

Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01

Primary outcomes

  1. The right coronary artery

    Time frame: Between baseline and 8 weeks follow up.

    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

Secondary outcomes

  1. The whole coronary tree

    Time frame: Between baseline and 8 weeks follow up.

    Change from baseline in the average pericoronary adipose tissue density of the whole coronary tree (main epicardial arteries ≥2mm).

  2. Ascending aorta

    Time frame: Between baseline and 8 weeks follow up.

    Change from baseline in the perivascular adipose tissue density of the ascending aorta

  3. Interleukin 1 beta (IL-1β)

    Time frame: Between baseline and 8 weeks follow up.

    Difference in peripheral blood IL-1β concentrations

  4. Tumor necrosis factor alpha (TNF-α)

    Time frame: Between baseline and 8 weeks follow up.

    Difference in peripheral blood TNF-α concentrations

  5. Interleukin-2 receptor (IL-2r)

    Time frame: Between baseline and 8 weeks follow up.

    Difference in peripheral blood IL-2r concentrations

  6. Interleukin Interleukin-6 (IL-6 )

    Time frame: Between baseline and 8 weeks follow up.

    Difference in peripheral blood IL-6 concentrations

  7. Ferritin

    Time frame: Between baseline and 8 weeks follow up.

    Difference in peripheral blood ferritin concentrations

  8. Troponin-I

    Time frame: At 8 weeks follow up.

    Differences in peripheral blood troponin-I concentrations between study groups

  9. N-terminal pro-B-type natriuretic peptide

    Time frame: At 8 weeks follow up.

    Differences in peripheral blood N-terminal pro-B-type natriuretic peptide concentrations between study groups

Other outcomes

  1. Explorative endpoints

    Time frame: 8 weeks follow up

    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

  2. Explorative endpoints

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Cajander, MD

CONTACT

[email protected]

+46196021042 ext. +46196021000

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Aarhus University Hospital
  • Cambridge University Hospitals NHS Foundation Trust
  • The Swedish Heart and Lung Association
  • University of Cambridge
  • Örebro University, Sweden

Registry information

Official study title

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

Acronym: ELIMINATE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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