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OpenTrials
Completed

NCT Number: NCT01953068

Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures

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).

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital Heart Center, Tampere, Pirkanmaa, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2)

Exclusion criteria

  • Previous neurological or psychiatric disorder.
  • Significant visual problem
  • Problems with upper arm/hand use

Treatment and study plan

Primary outcomes

  1. Executive Reaction Time Test response speed

    Time frame: 6 months

Secondary outcomes

  1. Executive Reaction Time Test: error% of answers

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2013
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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