SID-TAVI
Research type
Research Study
Full title
Stroke, inflammation and delirium after Transcatheter Aortic Valve Implantation
IRAS ID
289671
Contact name
Michael Fertleman
Contact email
Sponsor organisation
Research Governance and Integrity Team, Imperial College London
Duration of Study in the UK
2 years, 5 months, 4 days
Research summary
No studies have previously examined underlying brain biomarkers of inflammation and brain cell injury following Transcatheter Aortic Valve Implantation (TAVI), nor examined for correlation with vascular injury (cerebral microemboli) sustained during the procedure. In this study, conducted at Hammersmith Hospital, Imperial College Healthcare NHS Trust, we propose to examine cognitive tests, MRI scans, and blood and cerebrospinal fluid biomarkers at baseline, during the procedure, and following the procedure, and to examine for associations with delirium. Participants will be identified and recruited in outpatient cardiology clinic and multi-disciplinary meetings. Prior to the TAVI procedure they will attend for physical and cognitive assessments and an MRI scan at the Wellington Hospital. When they attend hospital for their TAVI procedure, they will undergo optional insertion of a spinal catheter just before the procedure, to enable cerebrospinal fluid collection at specific time points (baseline, during surgery, immediately after surgery and a day following surgery). They will also have blood tests drawn at the same time to allow comparisons. Participants will be examined by the research team post-procedure to examine for markers of mild neurological injury, delirium and cognitive impairment.
If the underlying cause or mechanisms of delirium following TAVI can be better understood then this will guide future research on modulatory or preventative therapies. Our findings will also further inform on the overall prognosis of cognitive impairment after cardiac procedures.
The study will be funded by a grant donation from a private donor to the chief investigator.
REC name
London - Harrow Research Ethics Committee
REC reference
21/PR/1430
Date of REC Opinion
3 Feb 2022
REC opinion
Further Information Favourable Opinion