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Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

NCT06336317 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-07

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • The Swedish Heart and Lung Association

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Sara Cajander, MD · Region Örebro län

  • Ole Frøbert, professor · Region Örebro län

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Denmark
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06336317 on ClinicalTrials.gov