Cognition Disorders, Fatigue, Heart Arrest, Out-Of-Hospital, Hypoxia-Ischemia, Brain, Insomnia, Psychological Distress
Conditions
Keywords
Neuropsychology
Brief summary
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.
Interventions
DIAGNOSTIC_TESTNeuropsychological assessment
Standardized neuropsychological battery consisting of the following tests and questionnaires: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Vocabulary, Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency, WAIS-IV Block Design, WAIS-IV Matrix Reasoning, WAIS-IV Digit Span, Wechsler Memory Scale - Third Edition (WMS-III) Spatial Span, Rey Auditory Verbal Learning Test (RAVLT), WMS-III Logical Memory, Brief Visuospatial Memory Test-Revised (BVMT-R), Trail Making Test (TMT) A & B, D-KEFS Color Word Interference Test, Behavioral Assessment of the Dysexecutive Syndrome Dysexecutive Questionnaire (BADS DEX), Multidimensional Fatigue Inventory (MFI-20), Minimal Insomnia Symptom Scale (MISS), Hospital Anxiety and Depression Scale (HADS).
Sponsors
Lund University
Halmstad County Hospital
Sahlgrenska University Hospital
Mid and South Essex NHS Foundation Trust
Cardiff and Vale University Health Board
Aarhus University Hospital
Region Skane
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive impairment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial | 7 months post-arrest | Validation of the neurocognitive screening battery in OHCA patients, using the detailed neuropsychological test battery as a gold standard with sensitivity and specificity analyses. Here, patients will be considered to have a cognitive impairment if they meet any of the following criteria on the neuropsychological tests: 1) an impaired composite z-score defined as z ≤ - 1.65 in at least one cognitive domain; 2) z ≤ - 1.65 in at least two scores used for cognitive domain calculation. Cut-scores for indicated impairment on the neurocognitive screening battery will be \< 26 on the MoCA, z≤-1 on the SDMT, ≥3.08 on the IQCODE-CA and the answer no to question 2 at the TSQ. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | 7 months, 24 months after the cardiac event | Longitudinal change in cognitive function in OHCA and MI patients, analyzed with a mixed model regression. |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed