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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Cognitive impairment
研究概览
简要总结
This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA).
This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial.
Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OHCA of a presumed cardiac or unknown cause (OHCA cohort only)
- •Sustained return of spontaneous circulation (ROSC) during intensive care - defined as 20 minutes with signs of circulation without the need for chest compressions (OHCA cohort only)
- •Unconsciousness - defined as not being able to obey verbal commands (FOUR-score motor response of <4) and no verbal response to pain after sustained ROSC (OHCA cohort only)
- •Inclusion within 180 minutes of ROSC (OHCA cohort only)
- •During intensive care - eligible for intensive care without restrictions or limitations (OHCA cohort only)
- •MI with performed coronary angiography (MI cohort only)
排除标准
- •Temperature on admission <30°C (OHCA cohort only)
- •On extracorporeal membrane oxygenation (ECMO) prior to return of spontaneous circulation (OHCA cohort only)
- •Obvious or suspected pregnancy
- •Intracranial bleeding (OHCA cohort only)
- •Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
- •Clinical dementia diagnosis before the event
- •Inability to speak the local language well enough to complete the assessment without assistance from an interpreter
- •Inability to meet for a face-to-face examination
- •Clinical Frailty Scale Index ≥8, indicating very severe frailty
- •Cardiac arrest before or in connection with MI (MI cohort only)
- •Active substance abuse
结局指标
主要结局
Cognitive impairment
时间窗: 7 months after the cardiac event
Cognitive function in OHCA and MI patients, using composite z-scores from the neuropsychological tests grouped by cognitive domain.
次要结局
- Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial(7 months post-arrest)