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NCT Number: NCT01946932

Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temperature treatment

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Azienda Ospedaliera Santa Maria Degli Angeli
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Copenhagen University Hospital, Denmark
  • Lund University
  • University Hospital of Wales

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2013
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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