Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Influenza vaccine, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction, Cardiovascular Diseases, Inflammatory Response. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Sweden, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
Overview
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.
Interventions
- 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
Primary outcome measures
- The right coronary artery [Time frame: Between baseline and 8 weeks follow up.]
Secondary outcome measures (9)
- The whole coronary tree [Time frame: Between baseline and 8 weeks follow up.]
- Ascending aorta [Time frame: Between baseline and 8 weeks follow up.]
- Interleukin 1 beta (IL-1β) [Time frame: Between baseline and 8 weeks follow up.]
- Tumor necrosis factor alpha (TNF-α) [Time frame: Between baseline and 8 weeks follow up.]
- Interleukin-2 receptor (IL-2r) [Time frame: Between baseline and 8 weeks follow up.]
- Interleukin Interleukin-6 (IL-6 ) [Time frame: Between baseline and 8 weeks follow up.]
- Ferritin [Time frame: Between baseline and 8 weeks follow up.]
- Troponin-I [Time frame: At 8 weeks follow up.]
- N-terminal pro-B-type natriuretic peptide [Time frame: At 8 weeks follow up.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital, Department of Cardiology — Aarhus
Sweden · 1 center
- Örebro University Hospital — Örebro
United Kingdom · 1 center
- Cambridge University Hospitals NHS Foundation Trust — Cambridge
Identifiers
NCT: NCT06336317 · ELIMINATE-2024