Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

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

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

Conditions4

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