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| Name | Class |
|---|---|
| Lund University | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Copenhagen University Hospital, Denmark | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Arrest 33° | Active Comparator | survivors with temperature treatment 33° |
|
| Cardiac Arrest survivors 36° | Active Comparator | survivors with temperature treatment 36° |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temperature treatment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rivermead Behavioural Memory Test (RBMT) | Memory test | 180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI) |
| Frontal Assessment Battery (FAB) | Screening of Executive functions | 180 days after CA or MI |
| Symbol Digit Modalities Test (SDMT) | Assess attention, mental speed and concentration | 180 days after CA or MI |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo-Portland Adaptability Inventory-4 (MPAI-4) | Self rating of impairments, adjustment, and participation (in the society) | 180 days after CA or MI |
| Short-Form Questionnaire 36 version 2 (SF-36v2) |
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Inclusion 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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Cronberg, MD, PhD | Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden | Study Chair |
| Niklas Nielsen, MD,PhD | Department of Clinical Sciences, Lund University, Lund Sweden and Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden | Principal Investigator |
| Jesper Kjaergaard, MD, PhD | The Heart Centrem Copenhagen University, Copenhagen, Denmark | Principal Investigator |
| Janneke Horn, MD, PhD | Department of Intensive Care, Academic Medical Centrum, Amsterdam, Netherlands | Principal Investigator |
| Tommaso Pellis, MD, PhD | Intensive Care Unit Santa Maria Degli Angeli, Pordenonde, Italy | Principal Investigator |
| Matthew P Wise, MD, PhD | Adult Critical Care, University Hospital of Wales, Cardiff, Untied Kingdom | Principal Investigator |
| Gisela Lilja, OT | Lund University Hospital, Lund, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | ||||
| San Martino Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19631442 | Background | 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. | |
| 22520518 | Background | 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. |
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| Azienda Ospedaliera Santa Maria Degli Angeli |
| OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| University Hospital of Wales | OTHER |
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Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
| 180 days after CA or MI |
| Zarit Burden Interview | Questionnaire for caregiver/informant/relative's perception of burden | 180 days after CA or MI |
| Hospital Anxiety and Depression rating Scale (HADS) | Anxiety and Depression questionnaire | 180 days after CA or MI |
| Two Simple Questions (TSQ) | Self rating of everyday activities and cognition | 180 days after CA or MI |
| Informant Questionnaire on Cognitive Decline (IQCODE) | Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver | 180 days after CA or MI |
| MiniMental Status Examination (MMSE) | General cognitive screening | 180 days after CA or MI |
| Cerebral Performance Category (CPC) | Scale for general neurological outcome | 180 days after CA or MI |
| modified Rankin Scale | Scale for general outcome | 180 days after CA or MI |
| 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 |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Karlstad Central Hospital | Karlstad | Sweden |
| Skåne University Hospital, Lund | Lund | Sweden |
| Skåne University Hospital, Malmö | Malmö | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| 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 | United Kingdom |
| 36164471 | Derived | Heimburg 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. |
| 29326145 | Derived | Lilja 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. |
| 26433116 | Derived | Lilja 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. |
| 25681466 | Derived | Lilja 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. |
| 24118853 | Derived | Lilja 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. |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D003072 | Cognition Disorders |
| D001930 | Brain Injuries |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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