Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

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.

Conditions

• Heart Arrest
• Out-of-hospital Cardiac Arrest
• Cognition Disorders
• Brain Injury

Interventions

OTHER

Temperature treatment

Sponsors & Collaborators

• Lund University

  collaborator OTHER

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

  collaborator OTHER

• Copenhagen University Hospital, Denmark

  collaborator OTHER

• Azienda Ospedaliera Santa Maria Degli Angeli

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• University Hospital of Wales

  collaborator OTHER

• Region Skane

  lead OTHER

Principal Investigators

• Tobias Cronberg, MD, PhD · Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden

• Niklas Nielsen, MD,PhD · Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden

• Jesper Kjaergaard, MD, PhD · The Heart Centrem Copenhagen University, Copenhagen, Denmark

• Janneke Horn, MD, PhD · Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands

• Tommaso Pellis, MD, PhD · Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy

• Matthew P Wise, MD, PhD · Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom

• Gisela Lilja, OT · Lund University Hospital, Lund, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• Denmark
• Italy
• Netherlands
• Sweden
• United Kingdom

Study Locations