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

NCT03579498 | Completed

• 1 other identifier: BH001
• Study Type: observational
• Target: 48
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Cardiac Arrest; Cognitive Function

Keywords

Cardiac arrest; Cognitive impairment; Depression; Anxiety; PTSD; Health- related quality of life; functional MRI

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (8)

• Health- related quality of life after cardiac arrest

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

• Depression after cardiac arrest according to MINI- interviews

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

• Depression after cardiac arrest according to MADRS-S

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

• Anxiety after cardiac arrest

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

• PTSD after cardiac arrest

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

Study Arms (2)

Patient group

Patients who have suffered a cardiac arrest at Uppsala University Hospital or who were admitted to this hospital after the event.

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (13)

• 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.

  PMID: 25596374 BACKGROUND

• 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.

  PMID: 12556909 BACKGROUND

• 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.

  PMID: 21856017 BACKGROUND

• 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.

  PMID: 12130784 BACKGROUND

• 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.

  PMID: 17635396 BACKGROUND

• 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.

  PMID: 24096198 BACKGROUND

• 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.

  PMID: 22984190 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 11964568 BACKGROUND

• 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.

  PMID: 12421743 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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.

  PMID: 20182373 BACKGROUND

• 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.

  PMID: 22092200 BACKGROUND

Related Links

• The EuroQol database

MeSH Terms

Conditions

Heart Arrest; Cognitive Dysfunction; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Sten Rubertsson, Prof, MD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anaesthesiology & Intensive Care Medicine

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: July 6, 2018
• Study Start: February 26, 2018
• Primary Completion: August 26, 2022
• Study Completion: November 1, 2023
• Last Updated: April 13, 2026

Record last verified: 2024-12

Locations

NO (1); SE (1)