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Looking for participantsPhase4

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

Sponsor: Region Örebro County

NCT ID: NCT06336317

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Influenza vaccine (biological), Placebo (biological)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
Influenza vaccine — biological: Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02 · Placebo — biological: Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at whether having the flu (influenza) vaccine after a heart attack (acute myocardial infarction) affects inflammation in the heart. It involves people who have had a specific type of heart attack called a non-ST-segment elevation myocardial infarction and who have had a procedure called a coronary PCI (percutaneous coronary intervention) to open a narrowed heart artery. The sponsor is Region Örebro County.

Who can take part

  • You have had a non-ST-segment elevation myocardial infarction (a type of heart attack)
  • Your coronary PCI (a procedure to open a heart artery) is finished
  • You are a man, or a woman who cannot become pregnant (for example, after the menopause or a hysterectomy), and you are 18 or older
  • You have given written informed consent
  • A heart scan (CCTA) can be scheduled within 7 days of your PCI

Who may not be able to

  • You had a flu vaccine in the last 6 months
  • You plan to have another vaccine within 8 weeks, including a COVID-19 booster
  • You have a severe egg allergy or have had an allergic reaction to a flu vaccine before
  • You have heart surgery or a further planned PCI within 8 weeks
  • You have a stent (small tube) in the proximal RCA (right coronary artery)
  • You may have a fever or an ongoing infection
  • You are allergic to the ingredients of Vaxigrip or to residues such as egg (ovalbumin or chicken proteins), neomycin, formaldehyde or octoxinol
  • You have a weakened immune system, from illness or medicines, that could reduce how well the vaccine works
  • You cannot give informed consent
  • You have taken part in the ELIMINATE trial before
  • You have another condition, such as cancer, giving a life expectancy under 1 year in the investigator's judgement
  • You cannot have a coronary CT angiography scan (for example, you cannot lie flat, cannot have glyceryl trinitrate, have a contrast allergy, have had contrast-induced kidney problems, or have severe kidney problems)
  • You have atrial fibrillation (an irregular heart rhythm)
  • You have an uncontrolled long-term inflammatory disease
  • You cannot follow the study requirements

What taking part involves

  • • Not stated — ask the trial team. The study involves the flu (influenza) vaccine, but details of what each group receives are not stated

Time commitment: A heart scan (CCTA) within 7 days after your PCI; other visits, duration and tests are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
90
Started
2024-04-24
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for acute myocardial infarction
  • • Phase4 - 90 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with acute myocardial infarction

Where?

  • • Cambridge - Cambridge University Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Acute Myocardial InfarctionCardiovascular DiseasesInflammatory Response

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Patients with a diagnosis of non-ST-segment elevation myocardial infarction
  • ✓A finalized coronary PCI
  • ✓Written agreement to take part
  • ✓A CCTA can be scheduled within 7 days after PCI

Who cannot take part

  • ✗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
  • ✗heart surgery or staged PCI planned within 8 weeks
  • ✗Coronary stent involving the proximal RCA
See the full 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

Where Is This Study? (1 UK site)

Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Joseph Cheriyan, Dr01223 336517jc403@cam.ac.uk

How to Get in Touch

Sara Cajander, MD

Sponsor contact

CONTACT

+46196021042 sara.cajander@oru.se
Data sourced from ClinicalTrials.gov · Last verified: 2025-07