Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial: A registry-based randomized clinical trialDepartment of Cardiology, University Hospital Lund, Lund, Sweden.
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Cardiology, University Hospital Uppsala, Uppsala, Sweden.
Department of Cardiology, University Hospital Uppsala, Uppsala, Sweden.
Cardiology, Heart Centre, department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Department of Cardiology, Västerås County Hospital, Västerås, Sweden.
The Feiring Clinic, Feiring, Norway.
Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, United States.
Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Cardiology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
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2017 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 189, p. 94-102Article in journal (Refereed) Published
Abstract [en]
Background: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI.
Methods/design: The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all cause death, a new AMI, or stent thrombosis at 1 year.
Implications: The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.
Place, publisher, year, edition, pages
Elsevier, 2017. Vol. 189, p. 94-102
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:oru:diva-58939DOI: 10.1016/j.ahj.2017.04.003ISI: 000404205000011PubMedID: 28625387Scopus ID: 2-s2.0-85018249396OAI: oai:DiVA.org:oru-58939DiVA, id: diva2:1134617
2017-08-212017-08-212024-01-16Bibliographically approved