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

NCT ID: NCT01953068

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Neurobehavioral Manifestations

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kati Järvelä

Kati järvelä, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonne Liimatainen, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Kaisa Hartikainen, Professor

Role: STUDY_DIRECTOR

Behavioral Neurology Research Unit, Pirkanmaa Hospital District

Arvi Yli-Hankala, Professor

Role: STUDY_DIRECTOR

Tampere University Hospital

Kati Järvelä, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital Heart Center

Locations

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Tampere University Hospital Heart Center

Tampere, Pirkanmaa, Finland

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 27245618 (View on PubMed)

Other Identifiers

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R13043

Identifier Type: -

Identifier Source: org_study_id

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