RecruitingACTRN12623001296628

Evaluate the effectiveness of Acute Flu Vaccination on Recurrent Cardiovascular Events (AFLUENT): A Pilot Randomised Clinical Trial


Sponsor

Royal Perth Hospital

Enrollment

300 participants

Start Date

May 9, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Having a heart attack significantly increases a person's risk of another major cardiac event — including another heart attack or even death. Influenza (the flu) is known to trigger heart attacks, and flu vaccination is strongly recommended for people with heart disease. Yet in practice, many patients who have just had a heart attack receive this advice and then never actually get vaccinated, or delay it until it's too late in the season to be protective. This pilot trial at Royal Perth Hospital is testing a simple but important strategy: offering influenza vaccination to heart attack patients while they are still in hospital (within one week of their event), rather than advising them to seek it out later. Half of participants will receive the flu vaccine in hospital; the other half will be advised to get it in the community as per current standard care. Eligible participants are adults who have had an acute Type 1 heart attack. People who have already had a flu vaccine in the past 3 months, have had a severe allergic reaction to the vaccine previously, or have Guillain-Barré syndrome history after vaccination are not eligible. This trial runs year-round, not just during flu season.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 compa

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.


Locations(1)

Royal Perth Hospital - Perth

WA, Australia

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ACTRN12623001296628


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