Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
- Conditions
- Acute Myocardial InfarctionCardiovascular DiseasesInflammatory Response
- Interventions
- Biological: Influenza vaccineBiological: Placebo
- Registration Number
- NCT06336317
- Lead Sponsor
- Region Örebro County
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaccination arm Influenza vaccine Influenza vaccine (Vaxigrip Tetra Sanofi Pasteur Europe). Placebo arm Placebo Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
- Primary Outcome Measures
Name Time Method The right coronary artery 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 Outcome Measures
Name Time Method Ascending aorta Between baseline and 8 weeks follow up. Change from baseline in the perivascular adipose tissue density of the ascending aorta
N-terminal pro-B-type natriuretic peptide At 8 weeks follow up. Differences in peripheral blood N-terminal pro-B-type natriuretic peptide concentrations between study groups
Interleukin Interleukin-6 (IL-6 ) Between baseline and 8 weeks follow up. Difference in peripheral blood IL-6 concentrations
The whole coronary tree 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).
Ferritin Between baseline and 8 weeks follow up. Difference in peripheral blood ferritin concentrations
Troponin-I At 8 weeks follow up. Differences in peripheral blood troponin-I concentrations between study groups
Interleukin 1 beta (IL-1β) Between baseline and 8 weeks follow up. Difference in peripheral blood IL-1β concentrations
Tumor necrosis factor alpha (TNF-α) Between baseline and 8 weeks follow up. Difference in peripheral blood TNF-α concentrations
Interleukin-2 receptor (IL-2r) Between baseline and 8 weeks follow up. Difference in peripheral blood IL-2r concentrations
Trial Locations
- Locations (1)
Örebro University Hospital
🇸🇪Örebro, Sweden