Brain Function After Cardiac Arrest (Measured With FMRI and Cognitive Tests)
NCT ID: NCT03579498
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2018-02-26
2023-05-01
Brief Summary
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The primary question is whether cognitive function is affected after cardiac arrest and whether it changes over time (during the first year after the event), compared with a healthy control group. Brain function during cognitive tasks and emotion processing will also be studied using functional MRI (fMRI). Another aim is to study whether clinical outcomes such as PTSD, anxiety and depression can be correlated with cognitive function and whether health- related quality of life is affected after a cardiac arrest.
The results from the cardiac arrest patient group will be compared with a healthy control group.
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Detailed Description
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Patients who are enrolled in the study will on three different occasions (in the acute phase, after six and after twelve months) answer questions regarding their health state and perform a computerized cognitive test and a behavioral test.
Patient/ control health status will be assessed through the following tests:
* Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCa) screening tool which measures attention/concentration, executive functions, memory, verbal skills, visual construction skills, abstract thinking, computation and orientation.
* Presence of delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM- ICU) and will be complemented with information from the patients' medical records.
* The Richmond Agitation - Sedation Scale (RASS) will be used to assess sedation.
* Health- related quality of life will be measured using the three level version of EQ-5D (EQ-5D-3L; Euro-Qol 5-Dimensions).
* A Mini International Neuropsychiatric Interview (MINI) will be performed to detect psychiatric syndromes (such as PTSD, anxiety and depression). Symptoms of anxiety and depression will also be measured using The Montgomery-Åsberg Depression Rating Scale- Self report (MADRS-S) and Impact of Event Scale-Revised -22. Alcohol use will be assessed using AUDIT (Alcohol Use Disorders Identification Test).
Information will also be collected from the patients' medical records.
Cognitive/ neuropsychological testing will be performed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), which measures amongst others memory, planning, executive functions and attention. For this study, the following CANTAB modules will be used:
* Delayed matching to sample (DMS)
* Paired associate learning test (PAL)
* Stockings of Cambridge (SOC)/ One Touch Stockings of Cambridge (OTS)
* Motor Screening Task (MOT), which provides a general assessment of whether sensorimotor deficits or lack of comprehension will limit the collection of valid data from the participant.
The tests are performed on a tablet. All task stimuli are non- verbal.
An approach- avoidance test that measures avoidance behavior will also be performed. Patients will be presented with auditory and visual (pictures) stimuli and will choose whether the stimuli presented to them will be of a neutral or aversive character. Patients will be informed that choosing the aversive stimuli will reward them with a small amount of money.
Functional magnetic resonance imaging (fMRI) will be performed six and twelve months after the cardiac arrest. The MRI scan will also include morphological images. The fMRI sequence will include tests regarding emotional activation, emotional memory and cognitive interference. A DMS task with emotionally loaded stimuli will be performed. Blood oxygenation level dependent (BOLD)- imaging will be used to produce the fMRI images, where differences in blood flow in different parts of the brain will be registered through echo planar imaging (EPI). The images will be analyzed with the Statistical Parametric Mapping (SPM)-12 program using MATLAB computing language.
The healthy control group will on two occasions (with the second occasion taking place six months after the first) answer questions regarding their health state, perform cognitive testing and fMRI. The same will be assessed for the control as for the patient group, with the exception of CAM-ICU, RASS and information from medical records, which will not be included in the control group.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient group
Patients who have suffered a cardiac arrest at Uppsala University Hospital or who were admitted to this hospital after the event.
No interventions assigned to this group
Control group
The control group will, as far as it is possible, match the patient group regarding mean age, age distribution, sex and educational attainments.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18-70
* Consents to participating in the study
Exclusion Criteria
* A history of brain injury or brain disease that affects cognitive function, such as dementia
* Severe psychiatric disorder, for example psychotic disorders or severe alcohol use disorder
* Insufficient knowledge of the spoken language to understand instructions and answer questionnaires (oral or written)
* Deceased within 1 month.
18 Years
70 Years
ALL
Yes
Sponsors
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Uppsala University
OTHER
Responsible Party
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Sten Rubertsson
Professor Anaesthesiology & Intensive Care Medicine
Principal Investigators
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Sten Rubertsson, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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Buanes EA, Gramstad A, Sovig KK, Hufthammer KO, Flaatten H, Husby T, Langorgen J, Heltne JK. Cognitive function and health-related quality of life four years after cardiac arrest. Resuscitation. 2015 Apr;89:13-8. doi: 10.1016/j.resuscitation.2014.12.021. Epub 2015 Jan 14.
Bush G, Shin LM, Holmes J, Rosen BR, Vogt BA. The Multi-Source Interference Task: validation study with fMRI in individual subjects. Mol Psychiatry. 2003 Jan;8(1):60-70. doi: 10.1038/sj.mp.4001217.
Cunningham JL, Wernroth L, von Knorring L, Berglund L, Ekselius L. Agreement between physicians' and patients' ratings on the Montgomery-Asberg Depression Rating Scale. J Affect Disord. 2011 Dec;135(1-3):148-53. doi: 10.1016/j.jad.2011.07.005.
Hariri AR, Mattay VS, Tessitore A, Kolachana B, Fera F, Goldman D, Egan MF, Weinberger DR. Serotonin transporter genetic variation and the response of the human amygdala. Science. 2002 Jul 19;297(5580):400-3. doi: 10.1126/science.1071829.
Larsson C, Axell AG, Ersson A. Confusion assessment method for the intensive care unit (CAM-ICU): translation, retranslation and validation into Swedish intensive care settings. Acta Anaesthesiol Scand. 2007 Aug;51(7):888-92. doi: 10.1111/j.1399-6576.2007.01340.x.
Larsson IM, Wallin E, Rubertsson S, Kristofferzon ML. Health-related quality of life improves during the first six months after cardiac arrest and hypothermia treatment. Resuscitation. 2014 Feb;85(2):215-20. doi: 10.1016/j.resuscitation.2013.09.017. Epub 2013 Oct 2.
Larsson IM, Wallin E, Rubertsson S, Kristoferzon ML. Relatives' experiences during the next of kin's hospital stay after surviving cardiac arrest and therapeutic hypothermia. Eur J Cardiovasc Nurs. 2013 Aug;12(4):353-9. doi: 10.1177/1474515112459618. Epub 2012 Sep 14.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Reinert DF, Allen JP. The Alcohol Use Disorders Identification Test (AUDIT): a review of recent research. Alcohol Clin Exp Res. 2002 Feb;26(2):272-9.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Sveen J, Orwelius L, Gerdin B, Huss F, Sjoberg F, Willebrand M. Psychometric properties of the Impact of Event Scale-Revised in patients one year after burn injury. J Burn Care Res. 2010 Mar-Apr;31(2):310-8. doi: 10.1097/BCR.0b013e3181d0f523.
Torgersen J, Hole JF, Kvale R, Wentzel-Larsen T, Flaatten H. Cognitive impairments after critical illness. Acta Anaesthesiol Scand. 2011 Oct;55(9):1044-51. doi: 10.1111/j.1399-6576.2011.02500.x. Epub 2011 Sep 8.
Related Links
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The EuroQol database
Other Identifiers
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BH001
Identifier Type: -
Identifier Source: org_study_id
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