Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

N/ACompletedNCT01946932

Region Skane287 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

287

Conditions

Heart Arrest Out-of-hospital Cardiac Arrest Cognition Disorders

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Rigshospitalet

Copenhagen, Denmark

San Martino Hospital

Genova, Italy

Santa Maria degli Angeli Hospital

Pordenone, Italy

Ospedale Universitario di Cattinaria

Trieste, Italy

Academisch Medisch Centrum (AMC)

Amsterdam, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Rijnstate Hospital

Arnhem, Netherlands

Leeuwarden Hospital

Leeuwarden, Netherlands

Sahlgrenska University Hospital, Thorax

Gothenburg, Sweden

Sahlgrenska University Hospital, Östra

Gothenburg, Sweden

...and 10 more locations

Outcomes

Primary Outcomes

Rivermead Behavioural Memory Test (RBMT)

Memory test

Time frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)

Frontal Assessment Battery (FAB)

Screening of Executive functions