None listed
Conditions
Brief summary
AFLUENT is a pragmatic, investigator initiated, open label, randomised, pilot clinical trial that will be undertaken within the Cardiology department at Royal Perth Hospital. This trial will compare an intervention of “early” routine influenza vaccination of patients diagnosed with acute myocardial infarction within one week of the event, to “standard care”, where patients will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their primary care physician. As per guideline recommendations, it is specifically recommended that “high risk” cardiac patients such as those within this study population receive their influenza vaccination in the community prior to the onset of “flu season”. However, enrolment of trial patients into AFLUENT will occur all year round, regardless of whether it is “flu season” or not. It is anticipated that patients within the “standard care” group may delay their vaccination or not receive it at all. Thus, the trial is testing a strategy of routine early administration to all patients in the intervention group, with currently recommended strategy whereby patients are encouraged to access vaccination in the community but often do not. The likely failure of many control patients to seek vaccination plus the inevitable delay in doing so are fundamental to the design of this trial.
Interventions
AFLUENT is a pragmatic, investigator initiated, open label, randomised, pilot clinical trial that will be undertaken within the Cardiology department at Royal Perth Hospital.
This trial will compare an intervention of “early” routine influenza vaccination of patients diagnosed with acute myocardial infarction within one week of the event, to “standard care”, where patients will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their prim
AFLUENT is a pragmatic, investigator initiated, open label, randomised, pilot clinical trial that will be undertaken within the Cardiology department at Royal Perth Hospital. This trial will compare an intervention of “early” routine influenza vaccination of patients diagnosed with acute myocardial infarction within one week of the event, to “standard care”, where patients will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their primary care physician. If a patient is randomised to the intervention of the influenza vaccination, a delegated research nurse who has undertaken an accredited immunisation course will administer the intramuscular vaccination prescribed by the treating physician on the Cardiology wards at Royal Perth Hospital.
Sponsors
Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Acute type 1 myocardial infarction
Exclusion criteria
a) Influenza vaccination in the previous 3 months b) Previous anaphylactic reaction to influenza vaccination c) Previous anaphylactic reaction to any component of influenza vaccine (if no suitable alternate vaccine is available) d) Intercurrent active infection or febrile illness e) Prior history of Guillain-Barré Syndrome within 6 weeks of previous influenza vaccination f) Other severe medical condition with life expectancy <1 year g) Unable or unwilling to provide informed consent.
Outcome results
None listed