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RECRUITINGPhase 4INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - A CCTA can be scheduled within 7 days after PCI Who Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Influenza vaccine

VaxigripTetra Suspension for injection, 0,5ml prefilled syringe ATC code: J07BB02

BIOLOGICAL

Placebo

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

Locations (2)

Aarhus University Hospital, Department of Cardiology
Aarhus, Denmark
Örebro University Hospital
Örebro, Sweden