Influenza vaccination After Myocardial Infarction (IAMI trial).A multicenter, prospective, randomized controlled clinical trial based on national angiography and angioplasty registries

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4400

Inclusion Criteria

- Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of =0.2 mV in leads V2-V3 and/or =0.1 mV in other leads or a probable new-onset left bundle branch block
Or:
- Patients with a diagnosis of NSTEMI defined by a combination of: onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an AMI.
Or:
- Patients with a diagnosis of stable coronary artery disease =75 years of age undergoing angiography/PCI AND with at least one additional risk criterion - previous myocardial infarction, previous PCI, previous CABG, diabetes mellitus, current smoking or an estimated glomerular filtration rate (eGFR) <40.
And:
- A finalized coronary angiography/PCI.
- Male or female subjects =18 years.
- Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2200

Exclusion Criteria

- Influenza vaccination during the current influenza season or the subject anticipating to be vaccinated during the current influenza season
- Indication for influenza vaccination for some indication other than Myocardial Infarction
- Severe allergy to eggs or previous allergic reaction to influence vaccine.
- 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 immunisation response.
- Inability to provide informed consent.
- Age below 18 years.
- Previous randomization in the IAMI trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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