BROCA-prediction: Brain outcome after cardiac arrest predictio

Recruiting

Conditions: Cardiac arrest, postanoxic encephalopathy

Registration Number: NL-OMON27782

Lead Sponsor: niversity of Twente, Clinical neurophysiology, Drienerlolaan 5 7522NB Enschede

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Age = 18 years
-Out of hospital cardiac arrest
-Successful cardiopulmonary resuscitation 4 +/- 3 weeks ago
-GCS score > 8
-Admission to cardiac care or cardiology department
-Written informed consent obtained

Exclusion Criteria

-Primary cause of arrest is choking or hanging
-Cardiac arrest and resuscitation started in the ambulance, on the way to the hospital, with return of spontaneous circulation and consciousness upon arrival at the hospital
-Preexistent brain damage with mRS>2
-Known progressive neurodegenerative disease
-Life expectancy of less than three months as a result of another medical condition
-Need of intravenous sedative medication
-Insufficient knowledge of the Dutch language to fill out questionnaires
-Patients with an MRI incompatible Implantable Cardioverter Defibrillator (ICD) may be excluded from the MRI protocol, depending on the ICD type. These patients can be included in the remainder of the study.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure (i.e. predicted outcome) is ‘restrictions in participation’ according to the restrictions subscale of the USER-P, dichotomized as ‘2 or more restrictions’ vs. ‘0 or 1 restriction’ at 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures (i.e. predicted outcomes) at 12 months include:<br>-Cognitive disturbances as measured by detailed NPE consisting of MoCA, 15 word test, RAVEN, Trail Making Test (TMT), Stroop, star cancellation, Boston Naming Test (BNT), and letter fluency<br>-Levels of activity as measured by USER-P and EQ5D-5L<br>-Emotional disturbances as measured by the Hospital Anxiety and Depression Scale (HADS)<br>-Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) and polysomnography<br>Determinants (i.e. independent variables) will be collected at 4 +/- 3 weeks after cardiac arrest and include demographic factors, clinical factors, MRI, and EEG measurements.