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New treatment option for Acute Myocardial Infarction
Official title Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
ClinicalTrials.gov ID: NCT06336317
What this study is testing
What is Influenza vaccine?
Influenza vaccine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for acute myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a diagnosis of non-ST-segment elevation myocardial infarction
- A finalized coronary PCI
- Male or non-fertile female people ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy...
- Written informed consent
- A CCTA can be scheduled within 7 days after PCI
You likely can't join if
- 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
See the full eligibility criteria
- Patients with a diagnosis of non-ST-segment elevation myocardial infarction
- A finalized coronary PCI
- Male or non-fertile female people ≥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
- 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
- people 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...
- Atrial fibrillation
- Uncontrolled chronic inflammatory disease
- Unable to comply with protocol requirements
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Örebro, Sweden
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Örebro, Sweden; Cambridge, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.