Clinical trial NCT03543371: Neuropsychological Outcome After Cardiac Arrest
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest, Out-Of-Hospital
Hypoxia-Ischemia, Brain
Cognition Disorders
Psychological Distress
Fatigue
Insomnia
Keywords: Neuropsychology
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Halmstad County Hospital
name: Sahlgrenska University Hospital
name: Mid and South Essex NHS Foundation Trust
name: Cardiff and Vale University Health Board
name: Aarhus University Hospital
First posted: 2018-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 - 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

Primary outcomes:
measure: Cognitive impairment
timeFrame: 7 months after the cardiac event
Secondary outcomes:
measure: Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial
timeFrame: 7 months post-arrest
Other outcomes:
measure: Change in cognitive function
timeFrame: 7 months, 24 months after the cardiac event
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad County Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Foundation Trust
state: Essex
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Cardiff and Vale University Health Board
state: Wales
Study officials:
affiliation: Lund University
name: Niklas Nielsen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Gisela Lilja, PhD, OT
role: STUDY_DIRECTOR
affiliation: Lund University
name: Tobias Cronberg, MD, PhD
role: STUDY_DIRECTOR
affiliation: Lund University
name: Susanna Vestberg, PhD, Lic.Psych.
role: STUDY_DIRECTOR
affiliation: Lund University
name: Erik Blennow Nordström, PhD, Lic.Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 after cardiac arrest: results from a sub-study of the targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest (TTM2) trial. Crit Care. 2023 Aug 26;27(1):328. doi: 10.1186/s13054-023-04617-0.