Neuropsychological Outcome After Cardiac Arrest
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cardiac Arrest survivors Cardiac arrest survivors at selected TTM2-sites only. |
Diagnostic Test: Neuropsychological 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).
|
| Myocardial Infarction patients A control group from a cohort of patients with myocardial infarction with performed coronary angiography but no occurrence of cardiac arrest will be recruited at 1:1 ratio. |
Diagnostic Test: Neuropsychological 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).
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus | Denmark | ||
| 2 | Sahlgrenska University Hospital | Göteborg | Sweden | ||
| 3 | Halmstad County Hospital | Halmstad | Sweden | ||
| 4 | Helsingborg Hospital | Helsingborg | Sweden | ||
| 5 | Skane University Hospital | Lund | Sweden | ||
| 6 | Skane University Hospital | Malmö | Sweden | ||
| 7 | The Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Foundation Trust | Basildon | Essex | United Kingdom | |
| 8 | University Hospital of Wales, Cardiff and Vale University Health Board | Cardiff | Wales | United Kingdom |
Sponsors and Collaborators
- Region Skane
- Lund University
- Halmstad County Hospital
- Sahlgrenska University Hospital, Sweden
- Mid and South Essex NHS Foundation Trust
- Cardiff and Vale University Health Board
- Aarhus University Hospital
Investigators
- Study Director: Niklas Nielsen, MD, PhD, Lund University
- Study Director: Gisela Lilja, PhD, OT, Lund University
- Study Director: Tobias Cronberg, MD, PhD, Lund University
- Study Director: Susanna Vestberg, PhD, Lic.Psych., Lund University
- Principal Investigator: Erik Blennow Nordström, MSc, Lic.Psych., Lund University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CardiacArrestLundNeuropsych