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

Sponsor:

Collaborators:

Lund University

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Copenhagen University Hospital, Denmark

Azienda Ospedaliera Santa Maria Degli Angeli

Copenhagen Trial Unit, Center for Clinical Intervention Research

University Hospital of Wales

Information provided by (Responsible Party):

Region Skane

Study Description

Brief Summary:

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	287 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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, Thorax
Gothenburg, Sweden
Sahlgrenska University Hospital, Östra
Gothenburg, Sweden
Sahlgrenska University Hospital
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

Azienda Ospedaliera Santa Maria Degli Angeli

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Cronberg T, Lilja G, Rundgren M, Friberg H, Widner H. Long-term neurological outcome after cardiac arrest and therapeutic hypothermia. Resuscitation. 2009 Oct;80(10):1119-23. doi: 10.1016/j.resuscitation.2009.06.021. Epub 2009 Jul 23.

Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langørgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thorén A, Undén J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lilja G, Nielsen N, Bro-Jeppesen J, Dunford H, Friberg H, Hofgren C, Horn J, Insorsi A, Kjaergaard J, Nilsson F, Pelosi P, Winters T, Wise MP, Cronberg T. Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003566. doi: 10.1161/CIRCOUTCOMES.117.003566.

Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Östman I, Cronberg T. Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.

Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Nilsson F, Pellis T, Wetterslev J, Wise MP, Bosch F, Bro-Jeppesen J, Brunetti I, Buratti AF, Hassager C, Hofgren C, Insorsi A, Kuiper M, Martini A, Palmer N, Rundgren M, Rylander C, van der Veen A, Wanscher M, Watkins H, Cronberg T. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33°C versus 36°C. Circulation. 2015 Apr 14;131(15):1340-9. doi: 10.1161/CIRCULATIONAHA.114.014414. Epub 2015 Feb 13.

Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial. BMC Cardiovasc Disord. 2013 Oct 12;13:85. doi: 10.1186/1471-2261-13-85.


Responsible Party:	Region Skane
ClinicalTrials.gov Identifier:	NCT01946932 History of Changes
Other Study ID Numbers:	TTMcogsub
First Posted:	September 20, 2013 Key Record Dates
Last Update Posted:	December 5, 2013
Last Verified:	August 2013

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 Cognitive Dysfunction Heart Arrest Out-of-Hospital Cardiac Arrest Cognition Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Neurocognitive Disorders Mental Disorders Heart Diseases Cardiovascular Diseases

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