NCT03543371

Neuropsychological Outcome After Cardiac Arrest

Completed Last updated 19 December 2025

What this trial tests

trial testing Neuropsychological assessment in Heart Arrest, Out-Of-Hospital in 200 participants. Completed in 23 May 2022.

Timeline

13 July 2018

Primary endpoint
11 January 2021

23 May 2022

Quick facts

Lead sponsor	Region Skane
Status	Completed
Study type	OBSERVATIONAL
Enrollment	200
Start date	13 July 2018
Primary completion	11 January 2021
Estimated completion	23 May 2022
Sites	8 locations across Denmark, United Kingdom, Sweden

Drugs / interventions tested

• Neuropsychological assessment

Conditions studied

• Heart Arrest, Out-Of-Hospital — all drugs for Heart Arrest, Out-Of-Hospital →
• Hypoxia-Ischemia, Brain — all drugs for Hypoxia-Ischemia, Brain →
• Cognition Disorders — all drugs for Cognition Disorders →
• Psychological Distress — all drugs for Psychological Distress →

Sponsor

Region Skane — full company profile →

Who can join

Adults 18 to 80, any sex, with Heart Arrest, Out-Of-Hospital or Hypoxia-Ischemia, Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Blennow Nordström E, Vestberg S, Evald L, Mion M, et al · · 2023 · cited 19× · PMID 37633944 · DOI 10.1186/s13054-023-04617-0
2. Combined use of the Montreal Cognitive Assessment and Symbol Digit Modalities Test improves neurocognitive screening accuracy after cardiac arrest: A validation sub-study of the TTM2 trial.
   Blennow Nordström E, Evald L, Mion M, Segerström M, et al · · 2024 · cited 16× · PMID 39147306 · DOI 10.1016/j.resuscitation.2024.110361
3. 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).
   Blennow Nordström E, Lilja G, Vestberg S, Ullén S, et al · · 2020 · cited 11× · PMID 33028221 · DOI 10.1186/s12872-020-01721-9
4. Physical activity after cardiac arrest; protocol of a sub-study in the Targeted Hypothermia versus Targeted Normothermia after Out-of-Hospital Cardiac Arrest trial (TTM2).
   Heimburg K, Lilja G, Tornberg ÅB, Ullén S, et al · · 2021 · cited 8× · PMID 34223342 · DOI 10.1016/j.resplu.2021.100076
5. 2-iminobiotin, a selective inhibitor of nitric oxide synthase, improves memory and learning in a rat model after four vessel occlusion, mimicking cardiac arrest.
   Peeters-Scholte C, Meilin S, Berckovich Y, Westers P. · · 2023 · cited 1× · PMID 37747911 · DOI 10.1371/journal.pone.0291915
6. Psychometric properties of the Dysexecutive Questionnaire (DEX) in individuals with a previous cardiac event.
   Vig A, Vestberg S, Evald L, Mion M, et al · · 2025 · PMID 41308659 · DOI 10.1080/09602011.2025.2591784