BROCA-prediction: Brain outcome after cardiac arrest prediction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27782

Enrollment

200

Registered

2021-05-02

Start date

2019-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac arrest, postanoxic encephalopathy

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcome measures (i.e. predicted outcomes) at 12 months include: - 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 - Levels of activity as measured by USER-P and EQ5D-5L - Emotional disturbances as measured by the Hospital Anxiety and Depression Scale (HADS) - Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) and polysomnography 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.	—

Measure

Time frame

Secondary outcome measures (i.e. predicted outcomes) at 12 months include: - 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 - Levels of activity as measured by USER-P and EQ5D-5L - Emotional disturbances as measured by the Hospital Anxiety and Depression Scale (HADS) - Sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) and polysomnography 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.

—

Contacts

Public ContactMarlous Verhulst

University of Twente

m.m.l.h.verhulst@utwente.nl+31(0)534891116

Outcome results