Clinical trial NCT06336317: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
Official title: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Cardiovascular Diseases
Inflammatory Response
Keywords: Coronary computed tomography angiography
Percutaneous coronary intervention
Influenza vaccine
Non ST-segment elevation myocardial infarction
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: The Swedish Heart and Lung Association
name: Örebro University, Sweden
name: University of Cambridge
First posted: 2024-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The right coronary artery
timeFrame: Between baseline and 8 weeks follow up.
Secondary outcomes:
measure: The whole coronary tree
timeFrame: Between baseline and 8 weeks follow up.
measure: Ascending aorta
timeFrame: Between baseline and 8 weeks follow up.
measure: Interleukin 1 beta (IL-1β)
timeFrame: Between baseline and 8 weeks follow up.
measure: Tumor necrosis factor alpha (TNF-α)
timeFrame: Between baseline and 8 weeks follow up.
measure: Interleukin-2 receptor (IL-2r)
timeFrame: Between baseline and 8 weeks follow up.
measure: Interleukin Interleukin-6 (IL-6 )
timeFrame: Between baseline and 8 weeks follow up.
measure: Ferritin
timeFrame: Between baseline and 8 weeks follow up.
measure: Troponin-I
timeFrame: At 8 weeks follow up.
measure: N-terminal pro-B-type natriuretic peptide
timeFrame: At 8 weeks follow up.
Other outcomes:
measure: Explorative endpoints
timeFrame: 8 weeks follow up
measure: Explorative endpoints
timeFrame: Baseline
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Region Örebro Län
name: Sara Cajander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Örebro Län
name: Ole Frøbert, professor
role: STUDY_CHAIR
References: