Brain Outcome after Cardiac Arrest - prediction

Brain Outcome after Cardiac Arrest - prediction - BROCA - prediction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55142

Enrollment

200

Registered

2019-04-12

Start date

2019-11-05

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

cardiac arrest heart attack

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  • Age >=18 years • Out of hospital cardiac arrest • Successful cardiopulmonary resuscitation <7 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 • 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 • Insufficient knowledge of the Dutch language to fill out questionnaires. 

Design outcomes

Primary

Measure	Time frame
The primary outcome measure 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. The International Classification of Functioning, Disability, and Health (ICF) is the WHO frame work for measuring health and disability. The ICF discriminates three levels of health related outcomes: functions, activities, and participation. Functional recovery in survivors after cardiac arrest largely manifests as societal participation. This concerns frequency of activi-ties, limitations/restrictions, and satisfaction about participation.28 These components are all included in USER-P. Internal consistency and discriminant validity of USER-P have been established in and outside the Netherlands amongst participants and patient groups with var-ious health conditions, including ischemic brain damage after cardiac arrest.28-30	—

Measure

Time frame

The primary outcome measure 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. The International Classification of Functioning, Disability, and Health (ICF) is the WHO frame work for measuring health and disability. The ICF discriminates three levels of health related outcomes: functions, activities, and participation. Functional recovery in survivors after cardiac arrest largely manifests as societal participation. This concerns frequency of activi-ties, limitations/restrictions, and satisfaction about participation.28 These components are all included in USER-P. Internal consistency and discriminant validity of USER-P have been established in and outside the Netherlands amongst participants and patient groups with var-ious health conditions, including ischemic brain damage after cardiac arrest.28-30

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Secondary

Measure	Time frame
Secondary outcome measures (i.e. predicted outcomes, i.e. dependent variables) are - On the level of functioning: cognitive disturbances at 12 months defined as a com-posite score based on neuropsychological examination (NPE). NPE at 12 months comprises: MoCA (general cognitive functioning), Star Cancellation Test (perception), Boston Naming Test (language), Rey Auditory Verbal Learning Test (memory), Trail Making Test part A & B (attention), Ravens Advanced Progressive Matrices (reason-ing), and Stroop Color and Word Test (executive functioning). - On the level of activities: frequency of activities according to the USER-P at 6 and 12 months. - On the level of participation: restriction in participation* at 6 months.	—

Measure

Time frame

Secondary outcome measures (i.e. predicted outcomes, i.e. dependent variables) are - On the level of functioning: cognitive disturbances at 12 months defined as a com-posite score based on neuropsychological examination (NPE). NPE at 12 months comprises: MoCA (general cognitive functioning), Star Cancellation Test (perception), Boston Naming Test (language), Rey Auditory Verbal Learning Test (memory), Trail Making Test part A & B (attention), Raven*s Advanced Progressive Matrices (reason-ing), and Stroop Color and Word Test (executive functioning). - On the level of activities: frequency of activities according to the USER-P at 6 and 12 months. - On the level of participation: *restriction in participation* at 6 months.

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Countries

Netherlands

Contacts

Public ContactJ Hofmeijer

Universiteit Twente

j.hofmeijer@utwente.nl0534895189

Outcome results