Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus
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(2020) 20:439
STUDY PROTOCOL
Open Access
Neuropsychological outcome after cardiac arrest: a prospective case control sub-study of the Targeted hypothermia versus targeted normothermia after out-ofhospital cardiac arrest trial (TTM2) Erik Blennow Nordström1* , Gisela Lilja1, Susanna Vestberg2, Susann Ullén3, Hans Friberg4, Niklas Nielsen5, Katarina Heimburg1, Lars Evald6, Marco Mion7, Magnus Segerström8, Anders M. Grejs9, Thomas Keeble7,10, Hans Kirkegaard9, Hanna Ljung1, Sofia Rose11, Matthew P. Wise12, Christian Rylander13, Johan Undén14 and Tobias Cronberg1
Abstract 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. (Continued on next page)
* Correspondence: [email protected] 1 Lund University, Skane University Hospital, Center for Cardiac Arrest at Lund University, Neurology Research Unit, Department of Clinical Sciences Lund, Neurology, Remissgatan 4, 221 85 Lund, Sweden Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This 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
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