Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
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|ClinicalTrials.gov Identifier: NCT01946932|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : December 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Arrest Out-of-hospital Cardiac Arrest Cognition Disorders Brain Injury||Other: Temperature treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||287 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Cognitive Impairment Following Cardiac Arrest and Target Temperature Management|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Active Comparator: Cardiac Arrest 33°
survivors with temperature treatment 33°
Other: Temperature treatment
Active Comparator: Cardiac Arrest survivors 36°
survivors with temperature treatment 36°
Other: Temperature treatment
- Rivermead Behavioural Memory Test (RBMT) [ Time Frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI) ]Memory test
- Frontal Assessment Battery (FAB) [ Time Frame: 180 days after CA or MI ]Screening of Executive functions
- Symbol Digit Modalities Test (SDMT) [ Time Frame: 180 days after CA or MI ]Assess attention, mental speed and concentration
- Mayo-Portland Adaptability Inventory-4 (MPAI-4) [ Time Frame: 180 days after CA or MI ]Self rating of impairments, adjustment, and participation (in the society)
- Short-Form Questionnaire 36 version 2 (SF-36v2) [ Time Frame: 180 days after CA or MI ]Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
- Zarit Burden Interview [ Time Frame: 180 days after CA or MI ]Questionnaire for caregiver/informant/relative's perception of burden
- Hospital Anxiety and Depression rating Scale (HADS) [ Time Frame: 180 days after CA or MI ]Anxiety and Depression questionnaire
- Two Simple Questions (TSQ) [ Time Frame: 180 days after CA or MI ]Self rating of everyday activities and cognition
- Informant Questionnaire on Cognitive Decline (IQCODE) [ Time Frame: 180 days after CA or MI ]Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
- MiniMental Status Examination (MMSE) [ Time Frame: 180 days after CA or MI ]General cognitive screening
- Cerebral Performance Category (CPC) [ Time Frame: 180 days after CA or MI ]Scale for general neurological outcome
- modified Rankin Scale [ Time Frame: 180 days after CA or MI ]Scale for general outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946932
|Study Chair:||Tobias Cronberg, MD, PhD||Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden|
|Principal Investigator:||Niklas Nielsen, MD,PhD||Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden|
|Principal Investigator:||Jesper Kjaergaard, MD, PhD||The Heart Centrem Copenhagen University, Copenhagen, Denmark|
|Principal Investigator:||Janneke Horn, MD, PhD||Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands|
|Principal Investigator:||Tommaso Pellis, MD, PhD||Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy|
|Principal Investigator:||Matthew P Wise, MD, PhD||Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom|
|Study Director:||Gisela Lilja, OT||Lund University Hospital, Lund, Sweden|