Influenza vaccination's effect on heart inflammation after a heart attack

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the immunological effects of influenza vaccination on arterial inflammation in patients who have recently experienced an acute myocardial infarction. It is a randomized, double-blind, placebo-controlled study where participants receive either the influenza vaccine or a placebo within 7 days following percutaneous coronary intervention. The primary goal is to assess whether vaccination can reduce coronary inflammation as measured by coronary computed tomography angiography at 8 weeks post-intervention. Blood tests will also be conducted to evaluate systemic inflammation and immune responses.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Sara Cajander, MD — Region Örebro län
• Study coordinator: Sara Cajander, MD
• Email: sara.cajander@oru.se
• Phone: +46196021042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.