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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579498
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sten Rubertsson, Uppsala University

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.


Condition or disease
Cardiac Arrest Cognitive Function

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Function After Cardiac Arrest (Measured With FMRI and Cognitive Tests)
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 26, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort
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.



Primary Outcome Measures :
  1. Cognitive function after cardiac arrest and changes over time [ Time Frame: 2-6 weeks, 6 and 12 months post- cardiac arrest ]
    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


Secondary Outcome Measures :
  1. Health- related quality of life after cardiac arrest [ Time Frame: 2-6 weeks, 6 and 12 months post- 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.


  2. Depression after cardiac arrest according to MINI- interviews [ Time Frame: 2-6 weeks, 6 and 12 months post- cardiac arrest ]
    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.

  3. Depression after cardiac arrest according to MADRS-S [ Time Frame: 2-6 weeks, 6 and 12 months post- cardiac arrest ]

    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.


  4. Anxiety after cardiac arrest [ Time Frame: 2-6 weeks, 6 and 12 months post- 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.

  5. PTSD after cardiac arrest [ Time Frame: 2-6 weeks, 6 and 12 months post- 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.

  6. Return to daily functioning after cardiac arrest according to questionnaires and interviews [ Time Frame: 2-6 weeks, 6 and 12 months post- cardiac arrest ]
    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.

  7. Prevalence of neuroanatomical deficits after cardiac arrest [ Time Frame: 6 months post- 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.

  8. Change in affective and cognitive processing, regional reactivity and connectivity measured through fMRI after cardiac arrest [ Time Frame: 6 and 12 months post- 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 Swedish language to understand instructions and answer questionnaires (oral or written)
  • Deceased within 1 month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579498


Contacts
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Contact: Sten Rubertsson, Prof, MD +46 708 693 996 sten.rubertsson@akademiska.se
Contact: Lisa Ekselius, Prof, MD 018-611 5227 lisa.ekselius@neuro.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Sten Rubertsson, Prof, MD    +46 708 693 996    sten.rubertsson@akademiska.se   
Contact: Lisa Ekselius, Prof, MD    018-611 5227    lisa.ekselius@neuro.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Sten Rubertsson, Prof, MD Uppsala University Hospital

Additional Information:
Publications:

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Responsible Party: Sten Rubertsson, Professor Anaesthesiology & Intensive Care Medicine, Uppsala University
ClinicalTrials.gov Identifier: NCT03579498    
Other Study ID Numbers: BH001
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sten Rubertsson, Uppsala University:
Cardiac arrest
Cognitive impairment
Depression
Anxiety
PTSD
Health- related quality of life
functional MRI
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases