Pilot Study of Cognitive and Functional Outcomes Following TAVI
Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cognitive and Functional Outcomes Following Transcatheter Aortic Valve Implantation (TAVI): a Pilot Study|
- Cognitive performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]The 30-minute neuropsychiatric assessment battery recommended by NINDS-CSN (National Institute of Neurological Disorders and Stroke- Canadian Stroke Network) harmonized standards
- Functional capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]The Timed Up and Go Test (TUG) and Hand Grip Strength Test
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-5L questionnaires
- Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]Centre for Epidemiologic Studies Depression Scale (CES-D)
- Apathy [ Time Frame: 6 months ] [ Designated as safety issue: No ]Apathy Evaluation Scale (AES)
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
transcatheter aortic valve implantation
This study recruits individuals that are undergoing transcatheter aortic valve implantation.
Cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70. In particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and is associated with reduced quality of life and increased mortality. TAVI has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (SAVR) with favourable outcomes long-term including improved functional capacity and quality of life. Recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g. cognitive decline) up to 1 year after TAVI in comparison to both SAVR and medical treatment. Studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after TAVI. In addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications. This study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after TAVI. We propose to recruit 34 patients for this study. Cognitive performance will be measured using a standardized cognitive battery prior to TAVI and 6 months post-TAVI. Functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to TAVI and 6 months post-TAVI. We hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after TAVI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02089945
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Krista L Lanctot, PhD 4164806100 ext 2241 firstname.lastname@example.org|
|Principal Investigator: Krista L Lanctot, PhD|
|Principal Investigator:||Krista L Lanctot, PhD||Sunnybrook Health Sciences Centre|