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

April 7, 2021 updated by: Kati Järvelä, Tampere University Hospital

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere university Hospital
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland
        • Tampere University Hospital Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Executive Reaction Time Test response speed
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Executive Reaction Time Test: error% of answers
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Kati Järvelä, MD, PhD, Tampere University Hospital Heart Center
  • Principal Investigator: Jonne Liimatainen, MD, Tampere university Hospital
  • Study Director: Kaisa Hartikainen, Professor, Behavioral Neurology Research Unit, Pirkanmaa Hospital District
  • Study Director: Arvi Yli-Hankala, Professor, Tampere university Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R13043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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