Influenza vaccination After Myocardial Infarction (IAMI trial).A multicenter, prospective, randomized controlled clinical trial based on the Swedish angiography and angioplasty registry (SCAAR) platform
- Conditions
- Myocardial infarctionMedDRA version: 20.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-001354-42-GB
- Lead Sponsor
- Örebro University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4400
- 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.
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: 0
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
- Influenza vaccination within 12 months prior to inclusion
- 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 Main Objective: In a multicenter, prospective, randomized registry-based controlled clinical trial based on the SCAAR and SWEDEHEART platforms compare influenza vaccination and placebo in reducing future major adverse cardiac and cerebrovascular events in patients with myocardial infarction.;Secondary Objective: Separate evaluation of each of the endpoints in the composite primary endpoint and time to revascularization, stroke, rehospitalization for heart failure and length of hospital stay.;Primary end point(s): The primary endpoint is time to all-cause death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year. These data will be obtained from national health registries. All primary endpoints up to 350 days will be adjudicated by a central adjudication committee.;Timepoint(s) of evaluation of this end point: One year after vaccination<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time to all-cause death till 1 year.<br>- Time to cardiovascular death till 1 year. <br>- Time to stent thrombosis till 1 year. <br>- Time to revascularization till 1 year. <br>- Time to myocardial infarction till 1 year.<br>- Time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year.<br>- Time to stroke till 1 year.<br>- Time to hospitalization for heart failure. <br>- Length of hospital stay.<br>;Timepoint(s) of evaluation of this end point: - Time to stent thrombosis after 1 year<br>- Time to revascularization after 1 year<br>- Time to myocardial infarction after 1 year<br>- Time to stroke after 1 year<br>- Time to rehospitalization for heart failure. <br>- Length of hospital stay