Heart ArrestNCT01946932
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
A study testing Temperature treatment in people with Heart Arrest and Out-of-hospital Cardiac Arrest, run by Region Skane at 20 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Out-of-hospital Cardiac Arrest, Cognition Disorders
- What is being tested?
- Temperature treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Jun 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
- Unconsciousness after sustained return of spontaneous circulation (ROSC)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Sweden8 sites
Sahlgrenska University Hospital, Thorax
Gothenburg
Sahlgrenska University Hospital, Östra
Gothenburg
Sahlgrenska University Hospital
Gothenburg
Helsingborg Hospital
Helsingborg
Karlstad Central Hospital
Karlstad
Skåne University Hospital, Lund
Lund
Skåne University Hospital, Malmö
Malmö
Örebro University Hospital
Örebro
Netherlands4 sites
Academisch Medisch Centrum (AMC)
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
Rijnstate Hospital
Arnhem
Leeuwarden Hospital
Leeuwarden
United Kingdom4 sites
Royal Bournemouth Hospital
Bournemouth
University Hospital of Wales
Cardiff
St Georges' Hospital
London
Royal Berkshire NHS Foundation Trust
Reading
Italy3 sites
San Martino Hospital
Genova
Santa Maria degli Angeli Hospital
Pordenone
Ospedale Universitario di Cattinaria
Trieste
About this study
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.
Read more
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.
- Being tested
- Temperature treatment
- Keywords
- Induced hypothermia, Mild induced hypothermia, Resuscitation, Therapeutic hypothermia, Neurological function, Cardiovascular diseases, Rehabilitation, Quality of life, Cognition
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Cognition Disorders, Brain Injuries, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Arrest 33° | Active comparator | survivors with temperature treatment 33° Receives: Other: Temperature treatment |
| Cardiac Arrest survivors 36° | Active comparator | survivors with temperature treatment 36° Receives: Other: Temperature treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Behavioural Memory Test (RBMT)
Memory test
Measured: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
Frontal Assessment Battery (FAB)
Screening of Executive functions
Measured: 180 days after CA or MI
Symbol Digit Modalities Test (SDMT)
Assess attention, mental speed and concentration
Measured: 180 days after CA or MI
Secondary outcomes (9)
Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Self rating of impairments, adjustment, and participation (in the society)
Measured: 180 days after CA or MI
Short-Form Questionnaire 36 version 2 (SF-36v2)
Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
Measured: 180 days after CA or MI
Zarit Burden Interview
Questionnaire for caregiver/informant/relative's perception of burden
Measured: 180 days after CA or MI
Hospital Anxiety and Depression rating Scale (HADS)
Anxiety and Depression questionnaire
Measured: 180 days after CA or MI
Two Simple Questions (TSQ)
Self rating of everyday activities and cognition
Measured: 180 days after CA or MI
Informant Questionnaire on Cognitive Decline (IQCODE)
Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
Measured: 180 days after CA or MI
MiniMental Status Examination (MMSE)
General cognitive screening
Measured: 180 days after CA or MI
Cerebral Performance Category (CPC)
Scale for general neurological outcome
Measured: 180 days after CA or MI
modified Rankin Scale
Scale for general outcome
Measured: 180 days after CA or MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJun 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Denmark, Azienda Ospedaliera Santa Maria Degli Angeli, Copenhagen Trial Unit, Center for Clinical Intervention Research, University Hospital of Wales
- Responsible party
- Sponsor
- Investigators
- Tobias Cronberg, MD, PhD, Study chair, Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, SwedenNiklas Nielsen, MD,PhD, Principal investigator, Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, SwedenJesper Kjaergaard, MD, PhD, Principal investigator, The Heart Centrem Copenhagen University, Copenhagen, DenmarkJanneke Horn, MD, PhD, Principal investigator, Department of Intensive Care, Academic Medical Centrum, Amsterdam, NetherlandsTommaso Pellis, MD, PhD, Principal investigator, Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, ItalyMatthew P Wise, MD, PhD, Principal investigator, Adult Critical Care, University Hospital of Wales, Cardiff, Untied KingdomGisela Lilja, OT, Study director, Lund University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946932
- Sponsor's protocol ID
- TTMcogsub
- Status last verified
- Aug 2013
- First submitted
- 12 Sep 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19631442Nielsen 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.
PubMed 22520518Heimburg K, Cronberg T, Tornberg AB, Ullen S, Friberg H, Nielsen N, Hassager C, Horn J, Kjaergaard J, Kuiper M, Rylander C, Wise MP, Lilja G. Self-reported limitations in physical function are common 6 months after out-of-hospital cardiac arrest. Resusc Plus. 2022 Jul 19;11:100275. doi: 10.1016/j.resplu.2022.100275. eCollection 2022 Sep.
PubMed 36164471Lilja G, Nielsen N, Bro-Jeppesen J, Dunford H, Friberg H, Hofgren C, Horn J, Insorsi A, Kjaergaard J, Nilsson F, Pelosi P, Winters T, Wise MP, Cronberg T. Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003566. doi: 10.1161/CIRCOUTCOMES.117.003566.
PubMed 29326145Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Ostman I, Cronberg T. Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.
PubMed 26433116Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Nilsson F, Pellis T, Wetterslev J, Wise MP, Bosch F, Bro-Jeppesen J, Brunetti I, Buratti AF, Hassager C, Hofgren C, Insorsi A, Kuiper M, Martini A, Palmer N, Rundgren M, Rylander C, van der Veen A, Wanscher M, Watkins H, Cronberg T. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33 degrees C versus 36 degrees C. Circulation. 2015 Apr 14;131(15):1340-9. doi: 10.1161/CIRCULATIONAHA.114.014414. Epub 2015 Feb 13.
PubMed 25681466Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial. BMC Cardiovasc Disord. 2013 Oct 12;13:85. doi: 10.1186/1471-2261-13-85.
PubMed 24118853
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
- ClinicalTrials.gov ID
- NCT01946932
- Acronym / sponsor ID
- TTMcogsub
- Keywords
- Induced hypothermia, Mild induced hypothermia, Resuscitation, Therapeutic hypothermia, Neurological function, Cardiovascular diseases, Rehabilitation, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Copenhagen University Hospital, Denmark, Azienda Ospedaliera Santa Maria Degli Angeli, Copenhagen Trial Unit, Center for Clinical Intervention Research, University Hospital of Wales
- Study start
- Jun 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Arrest 33° | Active comparator | Other: Temperature treatmentsurvivors with temperature treatment 33° |
| Cardiac Arrest survivors 36° | Active comparator | Other: Temperature treatmentsurvivors with temperature treatment 36° |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
- Unconsciousness after sustained return of spontaneous circulation (ROSC)
Key exclusion criteria (15 listed)
- Known bleeding diathesis
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature treatment | Other | Cardiac Arrest 33°, Cardiac Arrest survivors 36° |
Primary outcome
Rivermead Behavioural Memory Test (RBMT)
Time frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
Memory test
Frontal Assessment Battery (FAB)
Time frame: 180 days after CA or MI
Screening of Executive functions
Symbol Digit Modalities Test (SDMT)
Time frame: 180 days after CA or MI
Assess attention, mental speed and concentration
9 secondary outcomes
Mayo-Portland Adaptability Inventory-4 (MPAI-4)
Time frame: 180 days after CA or MI
Short-Form Questionnaire 36 version 2 (SF-36v2)
Time frame: 180 days after CA or MI
Zarit Burden Interview
Time frame: 180 days after CA or MI
Hospital Anxiety and Depression rating Scale (HADS)
Time frame: 180 days after CA or MI
Two Simple Questions (TSQ)
Time frame: 180 days after CA or MI
Informant Questionnaire on Cognitive Decline (IQCODE)
Time frame: 180 days after CA or MI
MiniMental Status Examination (MMSE)
Time frame: 180 days after CA or MI
Cerebral Performance Category (CPC)
Time frame: 180 days after CA or MI
modified Rankin Scale
Time frame: 180 days after CA or MI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Background: PubMed 19631442Cronberg 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.
- Background: PubMed 22520518Nielsen 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.
- Derived from this study: PubMed 36164471Heimburg K, Cronberg T, Tornberg AB, Ullen S, Friberg H, Nielsen N, Hassager C, Horn J, Kjaergaard J, Kuiper M, Rylander C, Wise MP, Lilja G. Self-reported limitations in physical function are common 6 months after out-of-hospital cardiac arrest. Resusc Plus. 2022 Jul 19;11:100275. doi: 10.1016/j.resplu.2022.100275. eCollection 2022 Sep.
- Derived from this study: PubMed 29326145Lilja G, Nielsen N, Bro-Jeppesen J, Dunford H, Friberg H, Hofgren C, Horn J, Insorsi A, Kjaergaard J, Nilsson F, Pelosi P, Winters T, Wise MP, Cronberg T. Return to Work and Participation in Society After Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003566. doi: 10.1161/CIRCOUTCOMES.117.003566.
- Derived from this study: PubMed 26433116Lilja G, Nilsson G, Nielsen N, Friberg H, Hassager C, Koopmans M, Kuiper M, Martini A, Mellinghoff J, Pelosi P, Wanscher M, Wise MP, Ostman I, Cronberg T. Anxiety and depression among out-of-hospital cardiac arrest survivors. Resuscitation. 2015 Dec;97:68-75. doi: 10.1016/j.resuscitation.2015.09.389. Epub 2015 Oct 9.
- Derived from this study: PubMed 25681466Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Nilsson F, Pellis T, Wetterslev J, Wise MP, Bosch F, Bro-Jeppesen J, Brunetti I, Buratti AF, Hassager C, Hofgren C, Insorsi A, Kuiper M, Martini A, Palmer N, Rundgren M, Rylander C, van der Veen A, Wanscher M, Watkins H, Cronberg T. Cognitive function in survivors of out-of-hospital cardiac arrest after target temperature management at 33 degrees C versus 36 degrees C. Circulation. 2015 Apr 14;131(15):1340-9. doi: 10.1161/CIRCULATIONAHA.114.014414. Epub 2015 Feb 13.
- Derived from this study: PubMed 24118853Lilja G, Nielsen N, Friberg H, Horn J, Kjaergaard J, Pellis T, Rundgren M, Wetterslev J, Wise MP, Nilsson F, Cronberg T. Cognitive function after cardiac arrest and temperature management; rationale and description of a sub-study in the Target Temperature Management trial. BMC Cardiovasc Disord. 2013 Oct 12;13:85. doi: 10.1186/1471-2261-13-85.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Cronberg, MD, PhD study chair
Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden
Niklas Nielsen, MD,PhD principal investigator
Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Jesper Kjaergaard, MD, PhD principal investigator
The Heart Centrem Copenhagen University, Copenhagen, Denmark
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temperature treatment in people with Heart Arrest and Out-of-hospital Cardiac Arrest, run by Region Skane at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Sweden, Netherlands, United Kingdom, Italy, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Behavioural Memory Test (RBMT) (time frame: 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946932, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.