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| Name | Class |
|---|---|
| Lund University | OTHER |
| Halmstad County Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Mid and South Essex NHS Foundation Trust |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Arrest survivors | Cardiac arrest survivors at selected TTM2-sites only. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological assessment | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive impairment | Cognitive function in OHCA and MI patients, using composite z-scores from the neuropsychological tests grouped by cognitive domain. | 7 months after the cardiac event |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function | Longitudinal change in cognitive function in OHCA and MI patients, analyzed with a mixed model regression. | 7 months, 24 months after the cardiac event |
Inclusion Criteria:
Exclusion Criteria:
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OHCA survivors at TTM2-sites participating in this study. Survivors are invited to partake in this study at the regular six-month follow-up of the TTM2-trial.
The cohort of MI patients acting as controls are recruited and assessed at one participating site per country through quality registers.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Erik Blennow Nordström, PhD, Lic.Psych. | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Sahlgrenska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028221 | Background | Blennow Nordstrom E, Lilja G, Vestberg S, Ullen S, Friberg H, Nielsen N, Heimburg K, Evald L, Mion M, Segerstrom M, Grejs AM, Keeble T, Kirkegaard H, Ljung H, Rose S, Wise MP, Rylander C, Unden J, Cronberg T. 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). BMC Cardiovasc Disord. 2020 Oct 7;20(1):439. doi: 10.1186/s12872-020-01721-9. | |
| 39147306 |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D020925 | Hypoxia-Ischemia, Brain |
| D003072 | Cognition Disorders |
| D005221 | Fatigue |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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| OTHER |
| Cardiff and Vale University Health Board | OTHER_GOV |
| Aarhus University Hospital | OTHER |
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|
| 7 months post-arrest |
| Gothenburg |
| Sweden |
| Halmstad County Hospital | Halmstad | Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Skane University Hospital | Lund | Sweden |
| Skane University Hospital | Malmö | Sweden |
| The Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Foundation Trust | Basildon | Essex | United Kingdom |
| University Hospital of Wales, Cardiff and Vale University Health Board | Cardiff | Wales | United Kingdom |
| Result |
| Blennow Nordstrom E, Evald L, Mion M, Segerstrom M, Vestberg S, Ullen S, Heimburg K, Gregersen Oestergaard L, Grejs AM, Keeble TR, Kirkegaard H, Rylander C, Wise MP, Lilja G. Combined use of the Montreal Cognitive Assessment and Symbol Digit Modalities Test improves neurocognitive screening accuracy after cardiac arrest: A validation sub-study of the TTM2 trial. Resuscitation. 2024 Sep;202:110361. doi: 10.1016/j.resuscitation.2024.110361. Epub 2024 Aug 13. |
| 41308659 | Result | Vig A, Vestberg S, Evald L, Mion M, Segerstrom M, Ullen S, Arestedt K, Nielsen N, Cronberg T, Lilja G, Blennow Nordstrom E. Psychometric properties of the Dysexecutive Questionnaire (DEX) in individuals with a previous cardiac event. Neuropsychol Rehabil. 2025 Nov 27:1-21. doi: 10.1080/09602011.2025.2591784. Online ahead of print. |
| 37633944 | Result | Blennow Nordstrom E, Vestberg S, Evald L, Mion M, Segerstrom M, Ullen S, Bro-Jeppesen J, Friberg H, Heimburg K, Grejs AM, Keeble TR, Kirkegaard H, Ljung H, Rose S, Wise MP, Rylander C, Unden J, Nielsen N, Cronberg T, Lilja G. Neuropsychological outcome after cardiac arrest: results from a sub-study of the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (TTM2) trial. Crit Care. 2023 Aug 26;27(1):328. doi: 10.1186/s13054-023-04617-0. |
| D002561 |
| Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |