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Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2)
BACKGROUND: This study is designed to provide detailed knowledge on cognitive impairment after out-of-hospital cardiac arrest (OHCA) and its relation to associated factors, and to validate the neurocognitive screening of the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Car...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542852/ https://www.ncbi.nlm.nih.gov/pubmed/33028221 http://dx.doi.org/10.1186/s12872-020-01721-9 |
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author | Blennow Nordström, Erik Lilja, Gisela Vestberg, Susanna Ullén, Susann Friberg, Hans Nielsen, Niklas Heimburg, Katarina Evald, Lars Mion, Marco Segerström, Magnus Grejs, Anders M. Keeble, Thomas Kirkegaard, Hans Ljung, Hanna Rose, Sofia Wise, Matthew P. Rylander, Christian Undén, Johan Cronberg, Tobias |
author_facet | Blennow Nordström, Erik Lilja, Gisela Vestberg, Susanna Ullén, Susann Friberg, Hans Nielsen, Niklas Heimburg, Katarina Evald, Lars Mion, Marco Segerström, Magnus Grejs, Anders M. Keeble, Thomas Kirkegaard, Hans Ljung, Hanna Rose, Sofia Wise, Matthew P. Rylander, Christian Undén, Johan Cronberg, Tobias |
author_sort | Blennow Nordström, Erik |
collection | PubMed |
description | BACKGROUND: This study is designed to provide detailed knowledge on cognitive impairment after out-of-hospital cardiac arrest (OHCA) and its relation to associated factors, and to validate the neurocognitive screening of the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2-trial), assessing effectiveness of targeted temperature management after OHCA. METHODS: This longitudinal multi-center clinical study is a sub-study of the TTM2-trial, in which a comprehensive neuropsychological examination is performed in addition to the main TTM2-trial neurocognitive screening. Approximately 7 and 24 months after OHCA, survivors at selected study sites are invited to a standardized assessment, including performance-based tests of cognition and questionnaires of emotional problems, fatigue, executive function and insomnia. At 1:1 ratio, a matched control group from a cohort of acute myocardial infarction (MI) patients is recruited to perform the same assessment. We aim to include 100 patients per group. Potential differences between the OHCA patients and the MI controls at 7 and 24 months will be analyzed with a linear regression, using composite z-scores per cognitive domain (verbal, visual/constructive, working memory, episodic memory, processing speed, executive functions) as primary outcome measures. Results from OHCA survivors on the main TTM2-trial neurocognitive screening battery will be compared with neuropsychological test results at 7 months, using sensitivity and specificity analyses. DISCUSSION: In this study we collect detailed information on cognitive impairment after OHCA and compare this to a control group of patients with acute MI. The validation of the TTM2 neurocognitive screening battery could justify its inclusion in routine follow-up. Our results may have a potential to impact on the design of future follow-up strategies and interventions after OHCA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03543371. Registered 1 June 2018 |
format | Online Article Text |
id | pubmed-7542852 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-75428522020-10-13 Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) Blennow Nordström, Erik Lilja, Gisela Vestberg, Susanna Ullén, Susann Friberg, Hans Nielsen, Niklas Heimburg, Katarina Evald, Lars Mion, Marco Segerström, Magnus Grejs, Anders M. Keeble, Thomas Kirkegaard, Hans Ljung, Hanna Rose, Sofia Wise, Matthew P. Rylander, Christian Undén, Johan Cronberg, Tobias BMC Cardiovasc Disord Study Protocol BACKGROUND: This study is designed to provide detailed knowledge on cognitive impairment after out-of-hospital cardiac arrest (OHCA) and its relation to associated factors, and to validate the neurocognitive screening of the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2-trial), assessing effectiveness of targeted temperature management after OHCA. METHODS: This longitudinal multi-center clinical study is a sub-study of the TTM2-trial, in which a comprehensive neuropsychological examination is performed in addition to the main TTM2-trial neurocognitive screening. Approximately 7 and 24 months after OHCA, survivors at selected study sites are invited to a standardized assessment, including performance-based tests of cognition and questionnaires of emotional problems, fatigue, executive function and insomnia. At 1:1 ratio, a matched control group from a cohort of acute myocardial infarction (MI) patients is recruited to perform the same assessment. We aim to include 100 patients per group. Potential differences between the OHCA patients and the MI controls at 7 and 24 months will be analyzed with a linear regression, using composite z-scores per cognitive domain (verbal, visual/constructive, working memory, episodic memory, processing speed, executive functions) as primary outcome measures. Results from OHCA survivors on the main TTM2-trial neurocognitive screening battery will be compared with neuropsychological test results at 7 months, using sensitivity and specificity analyses. DISCUSSION: In this study we collect detailed information on cognitive impairment after OHCA and compare this to a control group of patients with acute MI. The validation of the TTM2 neurocognitive screening battery could justify its inclusion in routine follow-up. Our results may have a potential to impact on the design of future follow-up strategies and interventions after OHCA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03543371. Registered 1 June 2018 BioMed Central 2020-10-07 /pmc/articles/PMC7542852/ /pubmed/33028221 http://dx.doi.org/10.1186/s12872-020-01721-9 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Blennow Nordström, Erik Lilja, Gisela Vestberg, Susanna Ullén, Susann Friberg, Hans Nielsen, Niklas Heimburg, Katarina Evald, Lars Mion, Marco Segerström, Magnus Grejs, Anders M. Keeble, Thomas Kirkegaard, Hans Ljung, Hanna Rose, Sofia Wise, Matthew P. Rylander, Christian Undén, Johan Cronberg, Tobias Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title | Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title_full | Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title_fullStr | Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title_full_unstemmed | Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title_short | Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (TTM2) |
title_sort | neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest trial (ttm2) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542852/ https://www.ncbi.nlm.nih.gov/pubmed/33028221 http://dx.doi.org/10.1186/s12872-020-01721-9 |
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