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Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial

Fröbert, Ole; Götberg, Matthias LU ; Angerås, Oskar; Jonasson, Lena; Erlinge, David LU ; Engstrøm, Thomas LU ; Persson, Jonas LU ; Jensen, Svend Eggert; Omerovic, Elmir and James, Stefan K., et al. (2017) In American Heart Journal 189. p.94-102
Abstract

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,... (More)

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.

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American Heart Journal
volume
189
pages
9 pages
publisher
Mosby
external identifiers
  • scopus:85018249396
  • wos:000404205000011
ISSN
0002-8703
DOI
10.1016/j.ahj.2017.04.003
language
English
LU publication?
yes
id
af1382ee-ab70-4f88-9ed5-dd9beb23f968
date added to LUP
2017-05-24 12:43:30
date last changed
2017-09-19 11:03:31
@article{af1382ee-ab70-4f88-9ed5-dd9beb23f968,
  abstract     = {<p>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.</p>},
  author       = {Fröbert, Ole and Götberg, Matthias and Angerås, Oskar and Jonasson, Lena and Erlinge, David and Engstrøm, Thomas and Persson, Jonas and Jensen, Svend Eggert and Omerovic, Elmir and James, Stefan K. and Lagerqvist, Bo and Nilsson, Johan and Kåregren, Amra and Moer, Rasmus and Yang, Cao and Agus, David B. and Erglis, Andrejs and Jensen, Lisette Okkels and Jakobsen, Lars and Christiansen, Evald H and Pernow, John},
  issn         = {0002-8703},
  language     = {eng},
  month        = {07},
  pages        = {94--102},
  publisher    = {Mosby},
  series       = {American Heart Journal},
  title        = {Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial},
  url          = {http://dx.doi.org/10.1016/j.ahj.2017.04.003},
  volume       = {189},
  year         = {2017},
}