Neuropsychological Outcome After Cardiac Arrest

Region Skane

Status: Completed

Conditions: Cognition Disorders; Insomnia; Fatigue; Hypoxia-Ischemia, Brain; Heart Arrest, Out-Of-Hospital; Psychological Distress

Treatments: Diagnostic Test: Neuropsychological assessment

Study type: Observational

Funder types: Other

Identifiers

NCT03543371

CardiacArrestLundNeuropsych

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Cardiac Arrest survivors

Description:

Cardiac arrest survivors at selected TTM2-sites only.

Treatment:

Diagnostic Test: Neuropsychological assessment

Myocardial Infarction patients

Description:

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.

Treatment:

Diagnostic Test: Neuropsychological assessment