Development of Risk Models for Cognitive Decline and Delirium in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

Not Applicable

• Conditions: Aortic stenosis; Delirium; Cognitive decline; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Mental Health - Other mental health disorders; Surgery - Other surgery

• Registration Number: ACTRN12618001114235
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-05
• Study Completion: 2022-05-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delirium assessed using the Confusion Assessment Method and the Confusion Assessment Method-ICU[ one and two days post TAVI];Cognitive decline measured using the Addenbrooke's Cognitive Examination and the Cambridge Neuropsychological Test Automated Battery [ 3-, 6- and 12- months post TAVI]

Secondary Outcome Measures

Name	Time	Method
Hospital acquired complications documented in the medical records as per the Australian Commission on Safety and Quality in Healthcare.<br>https://www.safetyandquality.gov.au/our-work/indicators/hospital-acquired-complications/<br>[ 30 days];Quality of life measured using the EuroQol[ 3-, 6- and 12- months post TAVI.];Delirium severity using the Memorial Delirium Assessment Scale[ one and two days post TAVI];Delirium subtype using Meagher's descriptions (2009).[ one and two days post TAVI];mortality[ 3-, 6- and 12- months post TAVI.];functional activity measured using the Barthel (modified) Index[ 3-, 6- and 12- months post TAVI]