None listed
Conditions
Brief summary
This study aims to identify risk factors for a deterioration in thinking and memory skills after a type of heart procedure known as transcatheter aortic valve implantation (TAVI). These changes may be short-term (such as delirium) or long-term cognitive decline. There will be 100 participants undergoing TAVI and 100 age-matched controls. Another part of this study will compare the 100 participants undergoing TAVI and the 100 control participants before the TAVI procedure i.e. the baseline data. This analysis will identify if participants with aortic stenosis compared with participants without aortic stenosis have different motor symptoms (walking, eye movement, voice, swallowing), mood, behaviour, brain activity (measured non-invasively using electroencephalogram or EEG), and their genotype taken from a saliva sample (with consent from participants).
Interventions
This study will identify possible risk factors for delirium (for two days post-procedurally) and cognitive decline (at 3-, 6- and 12-months post-procedurally) in older adults undergoing transcatheter aortic valve implantation. Possible risk factors include medical history, procedural variables and a range of baseline assessments (non-invasive brain imaging (EEG), APOE-e4 genotype from a saliva sample, and symptoms of frontostriatal dysfunction (gait characteristics, visual symptoms, voice asses
This study will identify possible risk factors for delirium (for two days post-procedurally) and cognitive decline (at 3-, 6- and 12-months post-procedurally) in older adults undergoing transcatheter aortic valve implantation. Possible risk factors include medical history, procedural variables and a range of baseline assessments (non-invasive brain imaging (EEG), APOE-e4 genotype from a saliva sample, and symptoms of frontostriatal dysfunction (gait characteristics, visual symptoms, voice assessment, and a range of questionnaires regarding swallowing, depression, anxiety, sleep disturbance and changes to behaviour). Participants will be required to complete a baseline assessment of 90 minutes duration, with the additional option of participating in the collection of resting EEG. The baseline assessment consists of questions about education, social and physical activity history, the Edmonton Frail Scale, The Addenbrooke's Cognitive Examination, CANTAB (The motor screening test, reaction time test and pattern recognition test), the Geriatric Depression Scale, insomnia items from the Hamilton Rating Scale for Depression, 6m gait task, dual 6m cognition/gait task, visual acuity, diplopia assessment, measuring of blink rate, one question from the Sydney Swallowing Questionnaire, three 5 second phonations of the vowel "ah" analysed using the iPad voice analyst app, the Neuropsychiatric Questionnaire, Euroqol-5D, and the Barthel Index (Modified). For two days following the TAVI procedure, participants will be assessed for delirium and delirium severity for a duration of 20 minutes using the Confusion Assessment Method and Memorial Delirium Assessment Scale. Follow-up of 60 minutes in duration will be completed at 3-, 6- and 12- months consisting of the Addenbrooke's Cognitive Examination, CANTAB (The motor screening test, reaction time test and pattern recognition test)Euroqol-5D, and the Barthel Index (Modified).
Sponsors
University of South Australia
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for the TAVI group include undergoing elective TAVI at the Royal Adelaide Hospital, male or female, and aged over 60 years. Participants with a clinical diagnosis of a neurodegenerative condition (including dementia) will be eligible for inclusion as it is reflective of the general older population who would be considered appropriate for cardiovascular procedures and thus will facilitate clinical translation of study results (note: different consent process for those with a clinical diagnosis of dementia). Inclusion criteria for the control group include male or female, and aged over 60 years. Participants with a clinical diagnosis of a neurodegenerative condition including dementia will be eligible for inclusion (note: different consent process for those with a clinical diagnosis of dementia).
Exclusion criteria
Key exclusion criteria include current or recent (within the past year) alcohol or substance abuse or dependence, use of recreational drugs (within the past month), a diagnosed learning disability, insufficient English language, hearing (with aids) or vision (with glasses) to complete assessment tasks. Control participants will be excluded if they are found to have a heart murmur and/or aortic stenosis, a history of cardiovascular disease. TAVI participants will be excluded if they are already enrolled in a TAVI clinical trial.
Outcome results
None listed