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Neuropsychological Outcome After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03543371
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Lund University
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Stockholm South General Hospital
Information provided by (Responsible Party):
Region Skane

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
Heart Arrest, Out-Of-Hospital Hypoxia-Ischemia, Brain Cognition Disorders Psychological Distress Fatigue Insomnia Diagnostic Test: Neuropsychological assessment

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuropsychological Outcome After Cardiac Arrest: A Sub-study of The Target Temperature Management 2 Trial
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort 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).




Primary Outcome Measures :
  1. Cognitive impairment [ Time Frame: 7 months after the event ]
    Cognitive function in OHCA and MI patients, using composite z-scores from the neuropsychological tests grouped by cognitive domain. Here, ≤-1 (1 standard deviation under the normative sample mean) is defined as a mildly to moderately impaired result, and a z-score of ≤-2 as a severely impaired result.


Secondary Outcome Measures :
  1. Change in cognitive and emotional function [ Time Frame: 7 months, 24 months after the event ]
    Longitudinal change in cognitive and emotional function in OHCA and MI patients, analyzed with a mixed model regression. Composite z-score from the neuropsychological tests grouped by cognitive domain, in which ≤-1 (1 standard deviation under the normative sample mean) is defined as a mildly to moderately impaired result, and a z-score of ≤-2 as a severely impaired result.

  2. Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial [ Time Frame: 7 months ]
    Validation of the neurocognitive screening battery in OHCA patients, using the detailed neuropsychological test battery as a gold standard with sensitivity and specificity analyses.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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 during intensive care - 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543371


Contacts
Contact: Erik Blennow Nordström, MSc +46725998946 erik.blennow_nordstrom@med.lu.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Christian Rylander, MD, PhD         
Halmstad County Hospital Recruiting
Halmstad, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Johan Undén, MD, PhD         
Helsingborg Hospital Recruiting
Helsingborg, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Martin Annborn, MD, PhD         
Skane University Hospital Recruiting
Lund, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Ola Borgquist, MD, PhD         
Skane University Hospital Recruiting
Malmö, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Hans Friberg, MD, PhD         
Stockholm South General Hospital Not yet recruiting
Stockholm, Sweden
Contact: Erik Blennow Nordström, MSc    +46725998946    erik.blennow_nordstrom@med.lu.se   
Principal Investigator: Per Nordberg, MD, PhD         
Sponsors and Collaborators
Region Skane
Lund University
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Stockholm South General Hospital
Investigators
Principal Investigator: Niklas Nielsen, MD, PhD Lund University
Study Director: Gisela Lilja, PhD, OT Lund University
Study Director: Tobias Cronberg, MD, PhD Lund University

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03543371     History of Changes
Other Study ID Numbers: CardiacArrestLundNeuropsych
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Skane:
Neuropsychology

Additional relevant MeSH terms:
Fatigue
Ischemia
Heart Arrest
Hypoxia
Cognition Disorders
Brain Ischemia
Hypoxia-Ischemia, Brain
Out-of-Hospital Cardiac Arrest
Signs and Symptoms
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Hypoxia, Brain