Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Study Overview
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Brief Summary
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This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest. The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction. Our secondary aims are: To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life. To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden. To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.

Official Title
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Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Conditions
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Heart Arrest, Out-of-hospital Cardiac Arrest, Cognition Disorders, Brain Injury

Intervention / Treatment
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* Other: Temperature treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause Unconsciousness after sustained return of spontaneous circulation (ROSC) Exclusion Criteria at time for inclusion in the TTM study: Known bleeding diathesis Suspected or confirmed acute intracranial bleeding Suspected or confirmed stroke Unwitnessed asystole Known limitations in therapy and Do Not Resuscitate-order Known disease making 180 days survival unlikely Known prearrest status Cerebral Performance Category (CPC)3 or 4 Temperature <30°on admission 4 hours (240 minutes) from ROSC to screening Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump In-hospital cardiac arrest OHCA of presumed non-cardiac arrest cause Additional Exclusion criteria for the sub-study: Disability to speak the site language well enough to complete tests without interpreter Controls should never have suffered a cardiac arrest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiac Arrest 33°<br>survivors with temperature treatment 33° | Other: Temperature treatment<br> <br> |
| Active Comparator: Cardiac Arrest survivors 36°<br>survivors with temperature treatment 36° | Other: Temperature treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Behavioural Memory Test (RBMT) | Memory test | 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI) | 
| Frontal Assessment Battery (FAB) | Screening of Executive functions | 180 days after CA or MI | 
| Symbol Digit Modalities Test (SDMT) | Assess attention, mental speed and concentration | 180 days after CA or MI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo-Portland Adaptability Inventory-4 (MPAI-4) | Self rating of impairments, adjustment, and participation (in the society) | 180 days after CA or MI | 
| Short-Form Questionnaire 36 version 2 (SF-36v2) | Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver | 180 days after CA or MI | 
| Zarit Burden Interview | Questionnaire for caregiver/informant/relative's perception of burden | 180 days after CA or MI | 
| Hospital Anxiety and Depression rating Scale (HADS) | Anxiety and Depression questionnaire | 180 days after CA or MI | 
| Two Simple Questions (TSQ) | Self rating of everyday activities and cognition | 180 days after CA or MI | 
| Informant Questionnaire on Cognitive Decline (IQCODE) | Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver | 180 days after CA or MI | 
| MiniMental Status Examination (MMSE) | General cognitive screening | 180 days after CA or MI | 
| Cerebral Performance Category (CPC) | Scale for general neurological outcome | 180 days after CA or MI | 
| modified Rankin Scale | Scale for general outcome | 180 days after CA or MI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced hypothermia, Mild induced hypothermia, Resuscitation, Therapeutic hypothermia, Neurological function, Cardiovascular diseases, Rehabilitation, Quality of life, Cognition