Neuropsychological Outcome After Cardiac Arrest

Insomnia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543371
• Other study ID #: CardiacArrestLundNeuropsych
• Status: Completed
• Start date: July 13, 2018
• Est. completion date: May 23, 2022

Study information

• Verified date: September 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 23, 2022
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Halmstad County Hospital	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Skane University Hospital	Lund
Sweden	Skane University Hospital	Malmö
United Kingdom	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

Sponsors (7)

Lead Sponsor	Collaborator
Region Skane	Aarhus University Hospital, Cardiff and Vale University Health Board, Halmstad County Hospital, Lund University, Mid and South Essex NHS Foundation Trust, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

References & Publications (2)

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. — View Citation

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 af — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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.	7 months post-arrest