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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03543371




Registration number
NCT03543371
Ethics application status
Date submitted
17/05/2018
Date registered
1/06/2018
Date last updated
21/09/2023

Titles & IDs
Public title
Neuropsychological Outcome After Cardiac Arrest
Scientific 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)
Secondary ID [1] 0 0
CardiacArrestLundNeuropsych
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest, Out-Of-Hospital 0 0
Hypoxia-Ischemia, Brain 0 0
Cognition Disorders 0 0
Psychological Distress 0 0
Fatigue 0 0
Insomnia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Neuropsychological assessment

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.


Diagnosis / Prognosis: 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).
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cognitive impairment
Timepoint [1] 0 0
7 months after the cardiac event
Secondary outcome [1] 0 0
Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial
Timepoint [1] 0 0
7 months post-arrest

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/05/2022
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus
Country [2] 0 0
Sweden
State/province [2] 0 0
Göteborg
Country [3] 0 0
Sweden
State/province [3] 0 0
Halmstad
Country [4] 0 0
Sweden
State/province [4] 0 0
Helsingborg
Country [5] 0 0
Sweden
State/province [5] 0 0
Lund
Country [6] 0 0
Sweden
State/province [6] 0 0
Malmö
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Essex
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Halmstad County Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sahlgrenska University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Mid and South Essex NHS Foundation Trust
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Cardiff and Vale University Health Board
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Aarhus University Hospital
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niklas Nielsen, MD, PhD
Address 0 0
Lund University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Blennow Nordstrom E, Vestberg S, Evald L, Mion M, ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT03543371