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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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, Sweden
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
Other
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03543371
Trial related presentations / publications
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.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03543371