Cognitive ImpairmentNCT04371172
Impact of TAVI on Cognition, Mood and Health-related Quality of Life
An observational study of Cognitive Impairment, run by Medical University of Graz at 1 site in Austria.
Trial summary
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive… Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- cognitive research battery, MRI, laboratory values
- How many people
- 128 participants
- Where
- 1 siteAustria
- Study dates
- 20 Feb 2023to 29 May 2025
- 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with percutaneous aortic valve replacement
Who may be able to join
- Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
- Women and men between the ages of 19 and 90
- Clinical indication for TAVI intervention
- No previous psychiatric illness before TAVI
- No other serious disease affecting the immune system
Who cannot join
- Non-compliance with the inclusion criteria
- Persons unable to give consent (e.g. dementia, delirium etc.)
- Magnetic resonance imaging (MR) contraindications
- ophthalmological inability to read
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.
Read the detailed description
The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.
In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.
- Conditions
- Cognitive Impairment
- Being tested
- cognitive research battery, MRI, laboratory values
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive research battery, MRI, laboratory valuesOther
cognitive research battery, MRI, laboratory values
| Study group | Role | What they receive |
|---|---|---|
| Patients with TAVI | cognitive research battery, MRI, laboratory values Receives: Other: cognitive research battery, MRI, laboratory values |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
Montreal-Cognitive-Assessment, cognitive test battery
Measured: 12 months
Secondary outcomes (1)
health-related quality of life
Short Form (36) Health Survey (SF-36): The SF-36 consists of 8 scales. scores. Each scale is directly transformed into a 0-100 scale. A score of 100 is equivalent to no disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start20 Feb 2023 (estimated)
- Primary completion29 May 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Baranyi, Medical University of Graz
- Investigators
- Andreas Baranyi, Prof., Principal investigator, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371172
- Sponsor's protocol ID
- 32-249 ex 19/20
- Other IDs
- 32-249 ex19/20
- Status last verified
- Jan 2023
- First submitted
- 29 Apr 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
- ClinicalTrials.gov ID
- NCT04371172
- Acronym / sponsor ID
- 32-249 ex 19/20
- Conditions
- Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 29 May 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 1 May 2020 (actual)
- 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.
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related Quality of life.
Detailed description
The percutaneous aortic valve replacement (TAVI, Transcatheter Aortic Valve Implantation) enables the implantation of a new biological aortic valve at the beating heart. The procedure is performed under local anaesthesia and is a gold standard in the therapy of aortic stenosis, especially in patients with a too high health risk for cardiovascular surgery.
In the proposed study, patients with and without embolic protection devices during TAVI will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a post-interventional period of 6 months after TAVI, with regard to the effects on mood, cognitive Performance and health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with TAVI | – | Other: cognitive research battery, MRI, laboratory valuescognitive research battery, MRI, laboratory values |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with percutaneous aortic valve replacement
Key inclusion criteria (5 listed)
- Written declaration of consent of the study participants to participate in the study after detailed information on the nature, significance, risks and scope of the study.
- Women and men between the ages of 19 and 90
- Clinical indication for TAVI intervention
- No previous psychiatric illness before TAVI
- No other serious disease affecting the immune system
Key exclusion criteria (4 listed)
- Non-compliance with the inclusion criteria
- Persons unable to give consent (e.g. dementia, delirium etc.)
- Magnetic resonance imaging (MR) contraindications
- ophthalmological inability to read
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive research battery, MRI, laboratory valuescognitive research battery, MRI, laboratory values | Other | Patients with TAVI |
Primary outcome
cognition
Time frame: 12 months
Montreal-Cognitive-Assessment, cognitive test battery
1 secondary outcome
health-related quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Andreas Baranyi, Prof. principal investigator
Medical University Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Baranyi, Prof. (0043-316-385-86241, an.baranyi@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2023.