Primary objective Primary objective is to create a prediction model based on early clinical screening of motor, cognitive, and emotional disturbances to predict restrictions in participation at one year after cardiac arrest in patients that have…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
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.
Background summary
Brain damage after cardiac arrest: an increasing health care problem
Cardiac arrest is the primary cause of death and disability in the Western
world. In the Netherlands alone, 16.000 persons are struck by a cardiac arrest
each year. Epidemiological studies predict a rising incidence because of an
increasing prevalence of cardiovascular risk factors and the aging population.1
Since the 1990s, survival rates of out of hospital cardiac arrest have
increased considerably in the Netherlands, from 16% in 2006 to 23-27% in 2016,
to even 41% in patients with a shockable rhythm. The exemplary increase in
survival in the Netherlands is related to national programs targeting awareness
of signs of cardiac arrest, education of basic life support to a wide range of
civilians, and dense networks of automated external defibrillators throughout
the country.2-4
In sharp contrast with increased survival, neurological outcome of cardiac
arrest survivors has changed only marginally over the past decades. Of those
surviving up to hospital admission, more than three quarters (approximately
5000 patients/y) initially remain comatose as a result of diffuse
anoxic-ischemic brain damage. Half of comatose patients die in the hospital.
Disturbances of motor functioning, cognition, mood, and functional impairments
have been recognized in up to 100% of survivors.5,6 Diagnosis and treatment are
focused on cardiac functioning, while brain damage and neurological impairments
are addressed infrequently and not systematically.7
Acute phase: comatose patients after cardiac arrest
With previous studies, we addressed prognosis and treatment of brain damage in
the acute phase after cardiac arrest. In this stage, most patients are
comatose. With prospective multicenter cohort studies, we have shown that
continuous EEG (cEEG) measures contribute to prediction of outcome in terms of
awakening from coma and functional recovery.8-11 This has resulted in inclusion
of cEEG in guidelines and implementation of cEEG in many hospitals, worldwide.
We currently investigate additional predictive values of advanced MRI
techniques in comatose patients,12 and test treatments with anti-epileptic
drugs and ghrelin to improve functional recovery in randomized controlled
clinical trials.13,14
Chronic phase: high incidence of cognitive and emotional disturbances
In a Dutch cohort of cardiac arrest survivors, at 1 year after the incident,
the incidence of cognitive disturbances was 22-29%, of posttraumatic stress
28%, of anxiety and depression 15%, and of severe fatigue 52%.15 Half of all
patients could not resume daily activities and three quarters showed
disturbances of participation in society.16 Cognitive impairments were strongly
related to reduced participation and reduced quality of life.17
No validated tools for prediction of cognitive disturbances or functional
recovery
Early recognition of disturbances of motor functioning, cognition, or mood
would allow better guidance of patients, and open avenues for targeted
treatments. However, there is no validated work up for diagnosis or prediction
of such disturbances, nor for the subsequent functional impairments. In some
hospitals, multidisciplinary screening programs analogous to those in patients
with ischemic stroke are used, but these are not tested in patients after
cardiac arrest. The Montreal Cognitive Assessment (MoCA) has been proposed for
detection of cognitive impairments18 and is tested by the group of van Heugten
and Verbunt in Limburg. Psychiatric disturbances have been recognized, but
reports on early screening are lacking.19,20 Prediction models for functional
recovery or participation are lacking.
MRI and EEG measurements of brain structure or functioning hold potential to
contribute to estimation of the nature and severity of brain damage. However,
after recovery of consciousness, EEG and MRI are not systematically included in
the work up of postanoxic encephalopathy (i.e. diffuse brain damage after
cardiac arrest). This is in sharp contrast to almost every other organic brain
disease, where imaging is the cornerstone of diagnosis. Since disturbances of
synaptic connectivity and cerebral network functioning are key
pathophysiological mechanisms in postanoxic encephalopathy21-25 and also
important for cognitive26 and mood outcomes,27 new EEG and MRI approaches
focusing on cerebral network functioning hold potential to contribute to
prediction of disturbances of cognition and mood. However, studies on MRI or
EEG (network) analysis in relation to motor, cognitive, or emotional
impairments, and consequent disabilities, of cardiac survivors are lacking.
General aims of the current study
With this study, we aim to establish a prediction model consisting of early
clinical parameters to predict neurological functional recovery of patients
after cardiac arrest that have survived the acute phase and awakened from coma.
Also, we will study additional predictive values of MRI and EEG measures.
Study objective
Primary objective
Primary objective is to create a prediction model based on early clinical
screening of motor, cognitive, and emotional disturbances to predict
restrictions in participation at one year after cardiac arrest in patients that
have survived the acute phase and awakened from coma.
Secondary objectives
Secondary objectives include:
• To create a prediction model based on early clinical screening to predict
cognitive disturbances at one year
• To create a prediction model based on early clinical screening to predict
level of activities at one year
• To study additional predictive values of EEG and MRI measurements
Study design
This will be a prospective, longitudinal cohort study on 200 patients after
cardiac arrest, ad-mitted on cardiac care units or cardiology departments.
Patients will be included, and clinical, MRI, and EEG measures of brain damage
will be collected at 4±3 weeks after cardiac arrest. In case of ICD
implantation before MRI data is collected, MRI will be postponed to 6 weeks
after ICD implantation (within 9 weeks after cardiac arrest). Follow up will be
one year. The study will start in Rijnstate Hospital, Arnhem. Various other
academic and non-academic hospitals have expressed the intention to participate
and will be added as participating centers later, by amendments.
Study burden and risks
Potential risk
We foresee no additional risk of clinical screening, MRI, or EEG measurements.
Potential benefit
Potential benefit from participating in this study is careful follow up, with
the possibility to identify and discuss signs of cognitive or emotional
disturbances, that would otherwise have remained uncovered.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69767.091.19 |