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

Ole Fröbert; Matthias Götberg; Oskar Angerås; Lena Jonasson; David Erlinge; Thomas Engstrøm; Jonas Persson; Svend E. Jensen; Elmir Omerovic; Stefan K. James; Bo Lagerqvist; Johan Nilsson; Amra Kåregren; Rasmus Moer; Cao Yang; David B. Agus; Andrejs Erglis; Lisette O. Jensen; Lars Jakobsen; Evald H. Christiansen; John Pernow

doi:10.1016/j.ahj.2017.04.003

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

Ole Fröbert^*, Matthias Götberg, Oskar Angerås, Lena Jonasson, David Erlinge, Thomas Engstrøm, Jonas Persson, Svend E. Jensen, Elmir Omerovic, Stefan K. James, Bo Lagerqvist, Johan Nilsson, Amra Kåregren, Rasmus Moer, Cao Yang, David B. Agus, Andrejs Erglis, Lisette O. Jensen, Lars Jakobsen, Evald H. ChristiansenJohn Pernow

^*Corresponding author for this work

28 Citations (Scopus)

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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, 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.

Original language	English
Journal	American Heart Journal
Volume	189
Pages (from-to)	94-102
Number of pages	9
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2017.04.003
Publication status	Published - Jul 2017
Externally published	Yes

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Fröbert, O., Götberg, M., Angerås, O., Jonasson, L., Erlinge, D., Engstrøm, T., Persson, J., Jensen, S. E., Omerovic, E., James, S. K., Lagerqvist, B., Nilsson, J., Kåregren, A., Moer, R., Yang, C., Agus, D. B., Erglis, A., Jensen, L. O., Jakobsen, L., ... Pernow, J. (2017). Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial. American Heart Journal, 189, 94-102. https://doi.org/10.1016/j.ahj.2017.04.003

Fröbert, O, Götberg, M, Angerås, O, Jonasson, L, Erlinge, D, Engstrøm, T, Persson, J, Jensen, SE, Omerovic, E, James, SK, Lagerqvist, B, Nilsson, J, Kåregren, A, Moer, R, Yang, C, Agus, DB, Erglis, A, Jensen, LO, Jakobsen, L, Christiansen, EH & Pernow, J 2017, 'Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial', American Heart Journal, vol. 189, pp. 94-102. https://doi.org/10.1016/j.ahj.2017.04.003

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

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, 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.",

author = "Ole Fr{\"o}bert and Matthias G{\"o}tberg and Oskar Anger{\aa}s and Lena Jonasson and David Erlinge and Thomas Engstr{\o}m and Jonas Persson and Jensen, {Svend E.} and Elmir Omerovic and James, {Stefan K.} and Bo Lagerqvist and Johan Nilsson and Amra K{\aa}regren and Rasmus Moer and Cao Yang and Agus, {David B.} and Andrejs Erglis and Jensen, {Lisette O.} and Lars Jakobsen and Christiansen, {Evald H.} and John Pernow",

year = "2017",

month = jul,

doi = "10.1016/j.ahj.2017.04.003",

language = "English",

volume = "189",

pages = "94--102",

journal = "American Heart Journal",

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T1 - Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial

AU - Fröbert, Ole

AU - Götberg, Matthias

AU - Angerås, Oskar

AU - Jonasson, Lena

AU - Erlinge, David

AU - Engstrøm, Thomas

AU - Persson, Jonas

AU - Jensen, Svend E.

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

PY - 2017/7

Y1 - 2017/7

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.

U2 - 10.1016/j.ahj.2017.04.003

DO - 10.1016/j.ahj.2017.04.003

M3 - Journal article

C2 - 28625387

AN - SCOPUS:85018249396

SN - 0002-8703

VL - 189

SP - 94

EP - 102

JO - American Heart Journal

JF - American Heart Journal

ER -

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

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