- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04371172
Impact of TAVI on Cognition, Mood and Health-related Quality of Life
The Impact of Transcatheter Aortic Valve Implantation on Cognition, Mood and Health-related Quality of Life - an Explorative Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Andreas Baranyi, Prof.
- Phone Number: 0043-316-385-86241
- Email: an.baranyi@medunigraz.at
Study Contact Backup
- Name: Albrecht Schmidt, PD.
- Phone Number: 0043-316-385
- Email: albrecht.schmidt@klinikum-graz.at
Study Locations
-
-
Styria
-
Graz, Styria, Austria, 8036
- Medical University of Graz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with TAVI
cognitive research battery, MRI, laboratory values
|
cognitive research battery, MRI, laboratory values
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cognition
Time Frame: 12 months
|
Montreal-Cognitive-Assessment, cognitive test battery
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
health-related quality of life
Time Frame: 12 months
|
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.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mood
Time Frame: 12 months
|
Hospital Anxiety and Depression Scale (HADS): A person can score between 0 and 21 for either anxiety or depression); Montgomery-Åsberg Depression Rating Scale: usual cutoff points are: 0 to 6 - normal, 7 to 19 - mild depression, 20 to 34 - moderate depression, >34 - severe Depression
|
12 months
|
MRI
Time Frame: 12 months
|
MRI
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Baranyi, Prof., Medical University Graz, Austria
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 32-249 ex 19/20
- 32-249 ex19/20 (Other Identifier: Ethikkommission, Medical university of Graz)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaNot yet recruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive Impairment
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University Health Network, TorontoRecruiting
-
Wake Forest University Health SciencesActive, not recruiting
Clinical Trials on cognitive research battery, MRI, laboratory values
-
University of RochesterRecruitingBreast Cancer Female | Cancer Related Cognitive DifficultiesUnited States
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesTerminatedParkinson's Disease | Healthy Controls Group - Age and Sex-matchedFrance
-
University of CambridgeGlobal Institute for Motorsport Safety (GIMSS) - Year 1; Neurolign Technologies... and other collaboratorsCompletedConcussion, Brain | Motor Vehicle AccidentUnited Kingdom
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedNeurotoxicity | Cognitive/Functional Effects | Psychosocial Effects of Cancer and Its Treatment | Adult Diffuse Astrocytoma | Adult Mixed Glioma | Adult Oligodendroglioma | SeizureUnited States, Canada
-
Case Comprehensive Cancer CenterRecruitingLymphoma | Myeloma | Stem Cell Transplant Complications | Allogeneic and Autologous Stem Cell TransplantUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteKite, A Gilead CompanyActive, not recruitingDiffuse Large B Cell Lymphoma | Transformed LymphomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); California Breast Cancer Research ProgramCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Ductal Breast Carcinoma in Situ | BRCA1 Mutation Carrier | BRCA2 Mutation Carrier | Lobular Breast Carcinoma in SituUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingNeuroblastoma | Ganglioneuroblastoma, NodularUnited States, Australia, Canada, New Zealand