Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis (IAMI)
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|ClinicalTrials.gov Identifier: NCT02831608|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : March 4, 2020
Background. For more than a century a causal link between influenza and cardiovascular disease has been suspected. It is conceivable that influenza may precipitate plaque rupture, increase cytokines with central roles in plaque destabilization and trigger the coagulation cascade. Accordingly, registry studies, case control studies and a few small randomized trials, all underpowered for clinical endpoints, have demonstrated that the risk for acute myocardial infarction (AMI) is increased following respiratory infection and that the risk of stroke and AMI in patients with established cardiovascular disease seem to be reduced following influenza vaccination. In May 2015 a Cochrane review concluded that influenza vaccination may reduce cardiovascular mortality and cardiovascular events but bias and inconsistent results in prior studies require higher-quality evidence to confirm these findings. High costs and little commercial interest in conducting a randomized trial on influenza vaccine in cardiovascular disease stand in the way.
Objective. The objective is to document whether influenza vaccination protects against cardiovascular events and death in patients with an AMI or very high risk stable coronary artery disease patients.
Methods. Population: 4400 patients with ST-elevation (STEMI), non-ST elevation myocardial infarction (NSTEMI) or very high risk stable coronary artery disease are randomized 1:1 in a blinded fashion using an RRCT design and followed up via registries and telephone calls. Intervention: Influenza vaccination. Control: Placebo (saline). Outcome: The primary endpoint is a composite of death, myocardial infarction and stent thrombosis till 1 year. Patients will be included in the study in all of Sweden's 7 university hospitals and 5 general hospitals, 4 university hospitals and 1 general hospital in Denmark, in 1 specialized heart center in Norway, 1 university hospitals in Czech Republic, 6 hospitals in Scotland, 1 university hospital in Latvia and 3 hospitals in Bangladesh. Secondary endpoints are time to all-cause death till 1 year, time to cardiovascular death till 1 year, time to stent thrombosis till 1 year, time to revascularization till 1 year, time to myocardial infarction till 1 year, time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year, time to stroke, including TIA till 1 year, time to rehospitalization for heart failure till 1 year or length of hospital stay (if information is available). From a hypothesis generating perspective we aim to follow up patients through registries beyond 1 year and up to 5 years. The trial has been approved by the ethical committee system (Dnr 2014/264) and the Medical Products Agency (EudraCTnr -2014-001354-42) in Sweden.
Perspectives. If a clinical benefit can be demonstrated in this prospective trial influenza vaccination may become an important novel in-hospital therapy for patients with cardiovascular disease and the accompanying direct and indirect societal gains will be profound.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Influenza, Human Influenza Vaccines Heart Failure Stroke||Biological: Influenza vaccine Biological: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Influenza Vaccination After Myocardial Infarction (IAMI Trial): A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on National Angiography and Angioplasty Registries|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Drug: influenza vaccine
Standard influenza vaccine administered as a deep subcutaneous injection at one occasion per subject.
Biological: Influenza vaccine
Other Name: Vaxigrip, Vaxigrip Tetra
Placebo Comparator: Drug: placebo
Saline administered as a deep subcutaneous injection at one occasion per subject.
- The number of participants with death, a new myocardial infarction or stent thrombosis (first occurring) according to ICD-10 codes. [ Time Frame: 1 year ]Composite endpoint of time to all-cause death, a new myocardial infarction or stent thrombosis (first occurring).
- The number of participants with stroke/transient ischemic attack according to ICD-10 codes. [ Time Frame: 1 year ]Time to stroke/transient ischemic attack will be registered.
- The number of participants with hospitalization for heart failure according to ICD-10 codes. [ Time Frame: 1 year ]Time to hospitalization for heart failure will be assessed.
- Length of hospital stay per participant. [ Time Frame: Pertains only to hospital stay at baseline. Realistic time frame: till 2 weeks ]Assessed by e-health records.
- The number of participants with: death, a new myocardial infarction or stent thrombosis assessed separately for each diagnosis according ICD-10 codes. [ Time Frame: 1 year ]Death, a new myocardial infarction or stent thrombosis will be reported as separate secondary endpoints.
- The number of participants with: cardiovascular death. [ Time Frame: 1 year ]Cardiovascular death will be reported as a separate secondary endpoint.
- Time to revascularization [ Time Frame: 1 year ]Unplanned revascularization following the index hospitalization
- The primary and secondary outcomes assessed beyond 1 year [ Time Frame: 5 years ]These outcomes will be considered exploratory only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831608
|Contact: Ole Frobert, MD, PhD||0046 19 602 54 email@example.com|
|Contact: Lotta Mazouch||0046 85 85 857 firstname.lastname@example.org|