NCT01953068

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

September 25, 2013

Last Update Submit

April 7, 2021

Conditions

Neurobehavioral Manifestations

Keywords

POCDExecutive Reaction Time TestAortic valve surgeryCognitive functionsTranscatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

  • Executive Reaction Time Test response speed

    6 months

Secondary Outcomes (1)

  • Executive Reaction Time Test: error% of answers

    6 months

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampere University Hospital Heart Center

Tampere, Pirkanmaa, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 27245618DERIVED

MeSH Terms

Conditions

Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonne Liimatainen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Kaisa Hartikainen, Professor

    Behavioral Neurology Research Unit, Pirkanmaa Hospital District

    STUDY DIRECTOR

  • Arvi Yli-Hankala, Professor

    Tampere University Hospital

    STUDY DIRECTOR

  • Kati Järvelä, MD, PhD

    Tampere University Hospital Heart Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kati järvelä, MD, PhD

Study Record Dates

First Submitted

September 25, 2013

First Posted

September 30, 2013

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

FI(2)