NCT06336317 Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
| NCT ID | NCT06336317 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Region Örebro County |
| Condition | Acute Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2024-04-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Sara Cajander, MD
PRINCIPAL INVESTIGATOR
Region Örebro län
Frequently Asked Questions
Who can join the NCT06336317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06336317 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06336317 currently recruiting?
Yes, NCT06336317 is actively recruiting participants. Contact the research team at sara.cajander@oru.se for enrollment information.
Where is the NCT06336317 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Örebro, Sweden, Cambridge, United Kingdom.
Who is sponsoring the NCT06336317 clinical trial?
NCT06336317 is sponsored by Region Örebro County. The principal investigator is Sara Cajander, MD at Region Örebro län. The trial plans to enroll 90 participants.