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Clinical Trials in Sweden / NCT06336317
Recruiting Phase 4

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

NCT06336317 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 4
Started
2024-04-24
Last updated
2026-04-07

Condition(s) studied

Acute Myocardial InfarctionCardiovascular DiseasesInflammatory Response

Investigational drug(s) / intervention(s)

Influenza vaccine →Placebo

Influenza vaccine: Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital, Department of Cardiology Aarhus Denmark Recruiting
Örebro University Hospital Örebro Sweden Recruiting
Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom Recruiting

More Region Örebro County trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06336317 on ClinicalTrials.gov ↗ ← All trials in Sweden