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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
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country

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/study/NCT03543371
Trial related presentations / publications
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/study/NCT03543371