Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
This study has been completed.
Sponsor:
Region Skane
Collaborators:
Lund University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Copenhagen University Hospital, Denmark
Intensive Care Unit, Santa Maria degli Angeli, Pordenone, Italy
Copenhagen Trial Unit, Center for Clinical Intervention Research
University Hospital of Wales
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01946932
First received: September 12, 2013
Last updated: December 4, 2013
Last verified: August 2013
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Purpose
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 | Intervention |
|---|---|
|
Heart Arrest Out-of-hospital Cardiac Arrest Cognition Disorders Brain Injury |
Other: Temperature treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Cognitive Impairment Following Cardiac Arrest and Target Temperature Management |
Resource links provided by NLM:
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Rivermead Behavioural Memory Test (RBMT) [ Time Frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI) ] [ Designated as safety issue: No ]Memory test
- Frontal Assessment Battery (FAB) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Screening of Executive functions
- Symbol Digit Modalities Test (SDMT) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Assess attention, mental speed and concentration
Secondary Outcome Measures:
- Mayo-Portland Adaptability Inventory-4 (MPAI-4) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Questionnaire for caregiver/informant/relative's perception of burden
- Hospital Anxiety and Depression rating Scale (HADS) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Anxiety and Depression questionnaire
- Two Simple Questions (TSQ) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Self rating of everyday activities and cognition
- Informant Questionnaire on Cognitive Decline (IQCODE) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
- MiniMental Status Examination (MMSE) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]General cognitive screening
- Cerebral Performance Category (CPC) [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Scale for general neurological outcome
- modified Rankin Scale [ Time Frame: 180 days after CA or MI ] [ Designated as safety issue: No ]Scale for general outcome
| Enrollment: | 287 |
| Study Start Date: | June 2011 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946932
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946932
Locations
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
| Italy | |
| San Martino Hospital | |
| Genova, Italy | |
| Santa Maria degli Angeli Hospital | |
| Pordenone, Italy | |
| Ospedale Universitario di Cattinaria | |
| Trieste, Italy | |
| Netherlands | |
| Academisch Medisch Centrum (AMC) | |
| Amsterdam, Netherlands | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands | |
| Rijnstate Hospital | |
| Arnhem, Netherlands | |
| Leeuwarden Hospital | |
| Leeuwarden, Netherlands | |
| Sweden | |
| Sahlgrenska University Hospital | |
| Gothenburg, Sweden | |
| Sahlgrenska University Hospital, Thorax | |
| Gothenburg, Sweden | |
| Sahlgrenska University Hospital, Östra | |
| Gothenburg, Sweden | |
| Helsingborg Hospital | |
| Helsingborg, Sweden | |
| Karlstad Central Hospital | |
| Karlstad, Sweden | |
| Skåne University Hospital, Lund | |
| Lund, Sweden | |
| Skåne University Hospital, Malmö | |
| Malmoe, Sweden | |
| Örebro University Hospital | |
| Örebro, Sweden | |
| United Kingdom | |
| Royal Bournemouth Hospital | |
| Bournemouth, United Kingdom | |
| University Hospital of Wales | |
| Cardiff, United Kingdom | |
| St Georges' Hospital | |
| London, United Kingdom | |
| Royal Berkshire NHS Foundation Trust | |
| Reading, United Kingdom | |
Sponsors and Collaborators
Region Skane
Lund University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Copenhagen University Hospital, Denmark
Intensive Care Unit, Santa Maria degli Angeli, Pordenone, Italy
Copenhagen Trial Unit, Center for Clinical Intervention Research
University Hospital of Wales
Investigators
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01946932 History of Changes |
| Other Study ID Numbers: | TTMcogsub |
| Study First Received: | September 12, 2013 |
| Last Updated: | December 4, 2013 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Region Skane:
|
Induced hypothermia Mild induced hypothermia Resuscitation Therapeutic hypothermia Neurological function |
Cardiovascular diseases Rehabilitation Quality of life Cognition |
Additional relevant MeSH terms:
|
Brain Injuries Cognition Disorders Heart Arrest Out-of-Hospital Cardiac Arrest Brain Diseases Cardiovascular Diseases Central Nervous System Diseases |
Craniocerebral Trauma Delirium, Dementia, Amnestic, Cognitive Disorders Heart Diseases Mental Disorders Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on February 26, 2015