Neuropsychological Outcome After Cardiac Arrest

Completed

• Conditions: Heart Arrest, Out-Of-Hospital; Psychological Distress; Fatigue; Hypoxia-Ischemia, Brain; Cognition Disorders; Insomnia
• Interventions: Diagnostic Test: Neuropsychological assessment

• Registration Number: NCT03543371
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Study Start: 2018-07-13
• Primary Completion: 2021-01-11
• Study Completion: 2022-05-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Arrest survivors	Neuropsychological assessment	Cardiac arrest survivors at selected TTM2-sites only.
Myocardial Infarction patients	Neuropsychological assessment	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.

Primary Outcome Measures

Name	Time	Method
Cognitive impairment	7 months after the cardiac event	Cognitive function in OHCA and MI patients, using composite z-scores from the neuropsychological tests grouped by cognitive domain.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the neurocognitive screening battery in the main TTM2-trial	7 months post-arrest	Validation of the neurocognitive screening battery in OHCA patients, using the detailed neuropsychological test battery as a gold standard with sensitivity and specificity analyses. Here, patients will be considered to have a cognitive impairment if they meet any of the following criteria on the neuropsychological tests: 1) an impaired composite z-score defined as z ≤ - 1.65 in at least one cognitive domain; 2) z ≤ - 1.65 in at least two scores used for cognitive domain calculation. Cut-scores for indicated impairment on the neurocognitive screening battery will be \< 26 on the MoCA, z≤-1 on the SDMT, ≥3.08 on the IQCODE-CA and the answer "no" to question 2 at the TSQ.

Trial Locations

Locations (7)

The Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals NHS Foundation Trust; 🇬🇧 Basildon, Essex, United Kingdom

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Skane University Hospital; 🇸🇪 Malmö, Sweden

Halmstad County Hospital; 🇸🇪 Halmstad, Sweden

University Hospital of Wales, Cardiff and Vale University Health Board; 🇬🇧 Cardiff, Wales, United Kingdom