Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Rivermead Behavioural Memory Test (RBMT) [ Time Frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI) ]
    Memory test

  2. Frontal Assessment Battery (FAB) [ Time Frame: 180 days after CA or MI ]
    Screening of Executive functions

  3. Symbol Digit Modalities Test (SDMT) [ Time Frame: 180 days after CA or MI ]
    Assess attention, mental speed and concentration


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Zarit Burden Interview [ Time Frame: 180 days after CA or MI ]
    Questionnaire for caregiver/informant/relative's perception of burden

  4. Hospital Anxiety and Depression rating Scale (HADS) [ Time Frame: 180 days after CA or MI ]
    Anxiety and Depression questionnaire

  5. Two Simple Questions (TSQ) [ Time Frame: 180 days after CA or MI ]
    Self rating of everyday activities and cognition

  6. 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

  7. MiniMental Status Examination (MMSE) [ Time Frame: 180 days after CA or MI ]
    General cognitive screening

  8. Cerebral Performance Category (CPC) [ Time Frame: 180 days after CA or MI ]
    Scale for general neurological outcome

  9. modified Rankin Scale [ Time Frame: 180 days after CA or MI ]
    Scale for general outcome


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 20 study locations
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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

Layout table for additonal information
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01946932    
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:
Layout table for MeSH terms
Brain Injuries
Heart Arrest
Out-of-Hospital Cardiac Arrest
Cognitive Dysfunction
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