Sponsor study identifier
observational
18
1 country
2
Study Start
January 2014
Actual (reported)Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. Conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time. The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2013
Actual (reported)September 30, 2013
Actual (reported)January 2014
Actual (reported)May 2016
Actual (reported)May 2016
Actual (reported)Executive Reaction Time Test response speed
6 months
Executive Reaction Time Test: error% of answers
6 months
Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center
Tampere University Hospital Heart Center
Tampere, Pirkanmaa, Finland
Tampere University Hospital
Tampere, 33521, Finland
Liimatainen J, Perakyla J, Jarvela K, Sisto T, Yli-Hankala A, Hartikainen KM. Improved cognitive flexibility after aortic valve replacement surgery. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):630-6. doi: 10.1093/icvts/ivw170. Epub 2016 May 30.
Jonne Liimatainen, MD
Tampere University Hospital
Kaisa Hartikainen, Professor
Behavioral Neurology Research Unit, Pirkanmaa Hospital District
Arvi Yli-Hankala, Professor
Tampere University Hospital
Kati Järvelä, MD, PhD
Tampere University Hospital
18 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2013
First Posted
September 30, 2013
Study Start
January 2014
Actual (reported)Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Contact the study team to confirm eligibility.
Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
April 8, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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