Neurobehavioral ManifestationsNCT01953068
Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
An observational study of Neurobehavioral Manifestations, run by Tampere University Hospital at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Neurobehavioral Manifestations
- How many people
- 18 participants
- Where
- 2 sitesFinland
- Study dates
- Jan 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center
Who may be able to join
- undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2)
Who cannot join
- Previous neurological or psychiatric disorder.
- Significant visual problem
- Problems with upper arm/hand use
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere University Hospital Heart Center
Tampere, Pirkanmaa
Tampere University Hospital
Tampere, 33521
About this study
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).
- Conditions
- Neurobehavioral Manifestations
- Keywords
- POCD, Executive Reaction Time Test, Aortic valve surgery, Cognitive functions, Transcatheter Aortic Valve Implantation
- Medical subject headings
- Neurobehavioral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Reaction Time Test response speed
Measured: 6 months
Secondary outcomes (1)
Executive Reaction Time Test: error% of answers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurobehavioral ManifestationsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kati Järvelä, Tampere University Hospital
- Investigators
- Jonne Liimatainen, MD, Principal investigator, Tampere University HospitalKaisa Hartikainen, Professor, Study director, Behavioral Neurology Research Unit, Pirkanmaa Hospital DistrictArvi Yli-Hankala, Professor, Study director, Tampere University HospitalKati Järvelä, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953068
- Sponsor's protocol ID
- R13043
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2013
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27245618
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
- ClinicalTrials.gov ID
- NCT01953068
- Acronym / sponsor ID
- R13043
- Conditions
- Neurobehavioral Manifestations
- Keywords
- POCD, Executive Reaction Time Test, Aortic valve surgery, Cognitive functions, Transcatheter Aortic Valve Implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center
Key inclusion criteria (1 listed)
- undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2)
Key exclusion criteria (3 listed)
- Previous neurological or psychiatric disorder.
- Significant visual problem
- Problems with upper arm/hand use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Executive Reaction Time Test response speed
Time frame: 6 months
1 secondary outcome
Executive Reaction Time Test: error% of answers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 27245618Liimatainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonne Liimatainen, MD principal investigator
Tampere University Hospital
Kaisa Hartikainen, Professor study director
Behavioral Neurology Research Unit, Pirkanmaa Hospital District
Arvi Yli-Hankala, Professor study director
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurobehavioral Manifestations, run by Tampere University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Reaction Time Test response speed (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01953068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.