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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01946932




Registration number
NCT01946932
Ethics application status
Date submitted
12/09/2013
Date registered
20/09/2013
Date last updated
5/12/2013

Titles & IDs
Public title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
Scientific title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
Secondary ID [1] 0 0
TTMcogsub
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest 0 0
Out-of-hospital Cardiac Arrest 0 0
Cognition Disorders 0 0
Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Temperature treatment

Active Comparator: Cardiac Arrest 33° - survivors with temperature treatment 33°

Active Comparator: Cardiac Arrest survivors 36° - survivors with temperature treatment 36°


Other interventions: Temperature treatment
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rivermead Behavioural Memory Test (RBMT)
Timepoint [1] 0 0
180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
Primary outcome [2] 0 0
Frontal Assessment Battery (FAB)
Timepoint [2] 0 0
180 days after CA or MI
Primary outcome [3] 0 0
Symbol Digit Modalities Test (SDMT)
Timepoint [3] 0 0
180 days after CA or MI
Secondary outcome [1] 0 0
Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Timepoint [1] 0 0
180 days after CA or MI
Secondary outcome [2] 0 0
Short-Form Questionnaire 36 version 2 (SF-36v2)
Timepoint [2] 0 0
180 days after CA or MI
Secondary outcome [3] 0 0
Zarit Burden Interview
Timepoint [3] 0 0
180 days after CA or MI
Secondary outcome [4] 0 0
Hospital Anxiety and Depression rating Scale (HADS)
Timepoint [4] 0 0
180 days after CA or MI
Secondary outcome [5] 0 0
Two Simple Questions (TSQ)
Timepoint [5] 0 0
180 days after CA or MI
Secondary outcome [6] 0 0
Informant Questionnaire on Cognitive Decline (IQCODE)
Timepoint [6] 0 0
180 days after CA or MI
Secondary outcome [7] 0 0
MiniMental Status Examination (MMSE)
Timepoint [7] 0 0
180 days after CA or MI
Secondary outcome [8] 0 0
Cerebral Performance Category (CPC)
Timepoint [8] 0 0
180 days after CA or MI
Secondary outcome [9] 0 0
modified Rankin Scale
Timepoint [9] 0 0
180 days after CA or MI

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
287
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Italy
State/province [2] 0 0
Genova
Country [3] 0 0
Italy
State/province [3] 0 0
Pordenone
Country [4] 0 0
Italy
State/province [4] 0 0
Trieste
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amsterdam
Country [6] 0 0
Netherlands
State/province [6] 0 0
Arnhem
Country [7] 0 0
Netherlands
State/province [7] 0 0
Leeuwarden
Country [8] 0 0
Sweden
State/province [8] 0 0
Gothenburg
Country [9] 0 0
Sweden
State/province [9] 0 0
Helsingborg
Country [10] 0 0
Sweden
State/province [10] 0 0
Karlstad
Country [11] 0 0
Sweden
State/province [11] 0 0
Lund
Country [12] 0 0
Sweden
State/province [12] 0 0
Malmoe
Country [13] 0 0
Sweden
State/province [13] 0 0
Örebro
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Bournemouth
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Cardiff
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Copenhagen University Hospital, Denmark
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Azienda Ospedaliera Santa Maria Degli Angeli
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Copenhagen Trial Unit, Center for Clinical Intervention Research
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University Hospital of Wales
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01946932
Trial related presentations / publications
Cronberg T, Lilja G, Rundgren M, Friberg H, Widner H. Long-term neurological outcome after cardiac arrest and therapeutic hypothermia. Resuscitation. 2009 Oct;80(10):1119-23. doi: 10.1016/j.resuscitation.2009.06.021. Epub 2009 Jul 23.
Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langorgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thoren A, Unden J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Tobias Cronberg, MD, PhD
Address 0 0
Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries