Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

This study has been completed.
Sponsor:
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
  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

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
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 October 22, 2014