Neuropsychological Outcome After Cardiac Arrest

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.

Conditions

• Heart Arrest, Out-Of-Hospital
• Hypoxia-Ischemia, Brain
• Cognition Disorders
• Psychological Distress
• Fatigue
• Insomnia

Interventions

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).

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Halmstad County Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Mid and South Essex NHS Foundation Trust

  collaborator OTHER

• Cardiff and Vale University Health Board

  collaborator OTHER_GOV

• Aarhus University Hospital

  collaborator OTHER

• Region Skane

  lead OTHER

Principal Investigators

• Niklas Nielsen, MD, PhD · Lund University

• Gisela Lilja, PhD, OT · Lund University

• Tobias Cronberg, MD, PhD · Lund University

• Susanna Vestberg, PhD, Lic.Psych. · Lund University

• Erik Blennow Nordström, PhD, Lic.Psych. · Lund University

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-13

Primary Completion

2021-01-11

Completion

2022-05-23

Countries

• Denmark
• Sweden
• United Kingdom

Study Locations