Influenza vaccination's effect on heart inflammation after a heart attack
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
This study is testing if getting a flu shot after a heart attack can help reduce inflammation in the heart for patients who have just had a procedure to open blocked arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Locations | 3 sites (Aarhus and 2 other locations) |
| Trial ID | NCT06336317 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a non-ST-segment elevation myocardial infarction and have undergone coronary PCI.
Not a fit: Patients who have received an influenza vaccination within the last 6 months or have other contraindications to vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of post-myocardial infarction inflammation, potentially enhancing recovery and reducing cardiovascular complications.
How similar studies have performed: While the specific approach of using influenza vaccination post-myocardial infarction is novel, related studies on vaccination and cardiovascular health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Aarhus and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.