Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
NCT ID: NCT06336317
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2024-04-24
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vaccination arm
Influenza vaccine (Vaxigrip Tetra Sanofi Pasteur Europe).
Influenza vaccine
VaxigripTetra Suspension for injection, 0,5ml prefilled syringe ATC code: J07BB02
Placebo arm
Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
Placebo
Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
Interventions
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Influenza vaccine
VaxigripTetra Suspension for injection, 0,5ml prefilled syringe ATC code: J07BB02
Placebo
Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Swedish Heart and Lung Association
OTHER
Örebro University, Sweden
OTHER
University of Cambridge
OTHER
Region Örebro County
OTHER
Responsible Party
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Principal Investigators
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Sara Cajander, MD
Role: PRINCIPAL_INVESTIGATOR
Region Örebro Län
Ole Frøbert, professor
Role: STUDY_CHAIR
Region Örebro Län
Locations
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Örebro University Hospital
Örebro, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ELIMINATE-2024
Identifier Type: -
Identifier Source: org_study_id
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