心脏骤停后的神经心理学结局：院外心脏骤停后目标低温与目标正常体温治疗试验（TTM2）的前瞻性病例对照亚研究。
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).
机构信息
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.
Lund University, Department of Psychology, Lund, Sweden.
出版信息
BMC Cardiovasc Disord. 2020 Oct 7;20(1):439. doi: 10.1186/s12872-020-01721-9.
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.
背景
本研究旨在提供关于院外心脏骤停（OHCA）后认知障碍及其与相关因素的关系的详细知识，并验证靶向低温与院外心脏骤停后目标正常体温治疗试验（TTM2 试验）的神经认知筛查，评估 OHCA 后靶向体温管理的有效性。
方法
这是一项纵向多中心临床研究，是 TTM2 试验的子研究，除了主要的 TTM2 试验神经认知筛查外，还进行了全面的神经心理学检查。在 OHCA 后约 7 个月和 24 个月，选择研究地点的幸存者被邀请进行标准化评估，包括认知表现测试和情绪问题、疲劳、执行功能和失眠问卷。以 1:1 的比例，从急性心肌梗死（MI）患者队列中招募匹配的对照组进行相同的评估。我们的目标是每个组纳入 100 名患者。使用每个认知域的复合 z 分数（言语、视觉/结构、工作记忆、情景记忆、处理速度、执行功能）作为主要结果指标，分析 OHCA 患者和 MI 对照组在 7 个月和 24 个月时的潜在差异。使用灵敏度和特异性分析，将 OHCA 幸存者在 TTM2 试验主要神经认知筛查电池上的结果与 7 个月时的神经心理学测试结果进行比较。
讨论
在这项研究中，我们收集了 OHCA 后认知障碍的详细信息，并将其与急性 MI 患者的对照组进行了比较。TTM2 神经认知筛查电池的验证可以证明其纳入常规随访的合理性。我们的结果可能对 OHCA 后未来随访策略和干预措施的设计产生影响。
试验注册
ClinicalTrials.gov，NCT03543371。注册于 2018 年 6 月 1 日。
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