Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Out-of-hospital Cardiac Arrest Clinical Trial

Official title:

Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946932
• Other study ID #: TTMcogsub
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: December 4, 2013
• Start date: June 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2013
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Other:
• Temperature treatment

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Italy	San Martino Hospital	Genova
Italy	Santa Maria degli Angeli Hospital	Pordenone
Italy	Ospedale Universitario di Cattinaria	Trieste
Netherlands	Academisch Medisch Centrum (AMC)	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Leeuwarden Hospital	Leeuwarden
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Sahlgrenska University Hospital, Östra	Gothenburg
Sweden	Sahlgrenska University Hospital, Thorax	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
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

Sponsors (7)

Lead Sponsor	Collaborator
Region Skane	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

Countries where clinical trial is conducted

Denmark,  Italy,  Netherlands,  Sweden,  United Kingdom, 

References & Publications (2)

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. — View Citation

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, Langørgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thorén A, Undén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rivermead Behavioural Memory Test (RBMT)	Memory test	180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)	No
Primary	Frontal Assessment Battery (FAB)	Screening of Executive functions	180 days after CA or MI	No
Primary	Symbol Digit Modalities Test (SDMT)	Assess attention, mental speed and concentration	180 days after CA or MI	No
Secondary	Mayo-Portland Adaptability Inventory-4 (MPAI-4)	Self rating of impairments, adjustment, and participation (in the society)	180 days after CA or MI	No
Secondary	Short-Form Questionnaire 36 version 2 (SF-36v2)	Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver	180 days after CA or MI	No
Secondary	Zarit Burden Interview	Questionnaire for caregiver/informant/relative's perception of burden	180 days after CA or MI	No
Secondary	Hospital Anxiety and Depression rating Scale (HADS)	Anxiety and Depression questionnaire	180 days after CA or MI	No
Secondary	Two Simple Questions (TSQ)	Self rating of everyday activities and cognition	180 days after CA or MI	No
Secondary	Informant Questionnaire on Cognitive Decline (IQCODE)	Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver	180 days after CA or MI	No
Secondary	MiniMental Status Examination (MMSE)	General cognitive screening	180 days after CA or MI	No
Secondary	Cerebral Performance Category (CPC)	Scale for general neurological outcome	180 days after CA or MI	No
Secondary	modified Rankin Scale	Scale for general outcome	180 days after CA or MI	No

External Links

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