TY - JOUR
T1 - Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial
T2 - A registry-based randomized clinical trial
AU - Frøbert, Ole
AU - Götberg, Matthias
AU - Angerås, Oskar
AU - Jonasson, Lena
AU - Erlinge, David
AU - Engstrøm, Thomas
AU - Persson, Jonas
AU - Jensen, Svend Eggert
AU - Omerovic, Elmir
AU - James, Stefan K
AU - Lagerqvist, Bo
AU - Nilsson, Johan
AU - Kåregren, Amra
AU - Moer, Rasmus
AU - Yang, Cao
AU - Agus, David B
AU - Erglis, Andrejs
AU - Jensen, Lisette O
AU - Jakobsen, Lars
AU - Christiansen, Evald H
AU - Pernow, John
N1 - Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1016/j.ahj.2017.04.003
DO - 10.1016/j.ahj.2017.04.003
M3 - Journal article
C2 - 28625387
SN - 0002-8703
VL - 189
SP - 94
EP - 102
JO - American Heart Journal
JF - American Heart Journal
ER -