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Cardiac ArrestBRAINnHEARTNCT03579498

Brain Function After Cardiac Arrest (Measured With FMRI and Cognitive Tests)

An observational study of Cardiac Arrest and Cognitive Function, run by Uppsala University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this longitudinal study is to determine whether brain function is affected after a cardiac arrest. 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiac Arrest, Cognitive Function
How many people
48 participants
Where
2 sitesin 2 countries
Study dates
26 Feb 2018to 1 Nov 2023
Phase
Observational
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population will consist of 30 cardiac arrest patients and 30 matched (regarding age, gender and educational level), healthy controls.

Who may be able to join

  • Patients who have suffered a cardiac arrest of cardiac cause who were admitted to hospital after the event.
  • Age 18-70
  • Consents to participating in the study

Who cannot join

  • Terminal disease with expected survival <1 year, moribund patient with >1 treatment limitations.
  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site
  • Haukeland University Hospital

    Bergen, 5021

Other trials in Norway

Sweden1 site
  • Uppsala University Hospital

    Uppsala, 75185

Other trials in Sweden

About this study

The aim of this longitudinal study is to determine whether brain function is affected after a cardiac arrest.

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.

Read the detailed description

The study is a prospective cohort study and aims to enroll 30 cardiac arrest patients and 30 matched (regarding age, gender and level of education), healthy controls.

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.

Keywords
Cardiac arrest, Cognitive impairment, Depression, Anxiety, PTSD, Health- related quality of life, functional MRI
Medical subject headings
Heart Arrest, Cognitive Dysfunction, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03579498
Study groupRoleWhat they receive
Patient groupPatients who have suffered a cardiac arrest at Uppsala University Hospital or who were admitted to this hospital after the event.
Control groupThe control group will, as far as it is possible, match the patient group regarding mean age, age distribution, sex and educational attainments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function after cardiac arrest and changes over time

    Cognitive function in cardiac arrest survivors according to CANTAB and MoCa. Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

Secondary outcomes (8)
  1. Health- related quality of life after cardiac arrest

    Health- related quality of life according to the three level (3L) version of Euro-Qol 5-Dimensions (5D), EQ-5D-3L, which consists of a descriptive system and a visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self- care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels from which the subject chooses the most appropriate statement : 1 (no problems), 2 (some problems) and 3 (extreme problems). The results are calculated as an index, ranging from -0,594 (death, or worse than death) to 1 (full health), based on normative data in the population. The EQ VAS is a scale where subjects rate their health from 0 (labeled "The worst health you can imagine) and 100 (labeled "The best health you can imagine).

    Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls and correlation with depression, anxiety, PTSD and cognitive function.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  2. Depression after cardiac arrest according to MINI- interviews

    Prevalence of depression according to MINI- interviews. Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls and correlation with cognitive function and health- related quality of life.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  3. Depression after cardiac arrest according to MADRS-S

    Prevalence of depression according to MADRS-S. The scale measures depressive symptoms and consists of nine items (mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life). Each item has seven levels (0-6, where higher scores indicate increased impairment) with described statements from which the subject chooses the most appropriate statement. The total score is then calculated as a sum of the individual scores. The total score ranges from 0 to 60 points and is interpreted as follows: 0-12 points: no depression/ essentially unaffected; 13-19 points: mild depression; 20-34 points: moderate depression; >34 points: severe depression.

    Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls and correlation with cognitive function and health- related quality of life.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  4. Anxiety after cardiac arrest

    Prevalence of anxiety according to MINI- interviews. Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls and correlation with cognitive function and health- related quality of life.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  5. PTSD after cardiac arrest

    Prevalence of post- traumatic stress syndrome (PTSD) according to MINI- interviews. Measured in the acute phase (2-6 weeks), 6 and 12 months post- cardiac arrest. Comparison with healthy controls and correlation with cognitive function and health- related quality of life.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  6. Return to daily functioning after cardiac arrest according to questionnaires and interviews

    Return to daily functioning in cardiac arrest survivors. In the acute phase (2-6 weeks) patients report current and previous (prior to the cardiac arrest) occupation and living arrangements. The same questions, as well as an interview regarding self- perceived return to daily life, will be answered at 6 and 12 months after the cardiac arrest. Return to daily functioning is defined as return to the same level of independence, living arrangements, occupation, family life, social interactions as well as engagement in leisure activities as prior to the cardiac arrest.

    Measured: 2-6 weeks, 6 and 12 months post- cardiac arrest

  7. Prevalence of neuroanatomical deficits after cardiac arrest

    Prevalence of neuroanatomical deficits, such as infarcts, after cardiac arrest. Visualized by first MRI (6 months post- cardiac arrest). Comparison with healthy controls.

    Measured: 6 months post- cardiac arrest

  8. Change in affective and cognitive processing, regional reactivity and connectivity measured through fMRI after cardiac arrest

    Change in affective and cognitive processing, regional reactivity and connectivity after cardiac arrest. Changes in regional oxygen consumption and blood flow during a DMS task with emotionally loaded stimuli will be assessed through fMRI. fMRI will be performed 6 and 12 months post- cardiac arrest. Comparison with healthy controls.

    Measured: 6 and 12 months post- cardiac arrest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start26 Feb 2018
  3. Primary completion26 Aug 2022
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579498
Sponsor's protocol ID
BH001
Acronym
BRAINnHEART
Status last verified
Dec 2024
First submitted
17 May 2018
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25596374
  • 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.

    PubMed 12556909
  • 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.

    PubMed 21856017
  • 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.

    PubMed 12130784
  • 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.

    PubMed 17635396
  • 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.

    PubMed 24096198
  • 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.

    PubMed 22984190
  • 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.

    PubMed 15817019
  • 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.

    PubMed 11964568
  • 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.

    PubMed 12421743
  • 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.

    PubMed 9881538
  • 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.

    PubMed 20182373
  • 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.

    PubMed 22092200

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest and Cognitive Function, run by Uppsala University at 2 sites in 2 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 5 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Sweden. 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?

Cognitive function after cardiac arrest and changes over time (time frame: 2-6 weeks, 6 and 12 months post- cardiac arrest). 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 NCT03579498, which also lists 13 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 13 Apr 2026.

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