CAPITA: Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

Sponsor

Ronak Delewi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05481008

Collaborator

(none)

142

Enrollment

Location

35.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: Cardiovascular disease and cognitive diseases are closely related. Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed that increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with increased cerebral blood flow. It is hypothesized that increased cerebral blood flow (CBF) subsequently leads to improved cognitive functioning. Additionally, silent micro emboli caused by crushing of the calcified native valve during TAVI may cause cognitive deterioration. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these patients could benefit from cerebral protection devices, preventing cognitive decline.

Objective: The objectives of the CAPITA study are 1A) to identify whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) explore regional differences in CBF after TAVI; 1C) determine whether (global or regional) increased CBF is associated with improved cognitive functioning; 1D) identify patient and procedural characteristics associated with increased cardiac output, CBF and cognitive functioning; 2A) identify the incidence and volume of new white matter hyperintensities after TAVI; 2B) evaluate patient and procedural predictors for the increase in white matter hyperintensities volume, including baseline aortic valve calcification volume, measured with computed tomography; 2C) if aortic valve calcification volume predicts new white matter hyperintensities, define a cut-off value for high-risk patients; 2D) assess whether the increase in white matter hyperintensity volume is associated with deterioration of cognitive scores.

Study design: Prospective observational study, measuring cardiac output (echocardiography), cerebral blood flow (arterial spin labelling magnetic resonance imaging) and cognitive functioning (neuropsychological test battery) prior to TAVI (<24 hours to <one week) and at 3 months follow-up. At one year follow-up, cardiac output and cognitive function will be assessed.

Study population: Patients with severe aortic valve stenosis eligible for transfemoral TAVI (n=142).

Main study parameters/endpoints: Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive neuropsychological testing 60-90 minutes).

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Cognitive Impairment Cognitive Change	Device: transcatheter aortic valve implantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

142 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiac Output, Cerebral Perfusion and Cognition in Patients With Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation

Actual Study Start Date :

Aug 28, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Outcome Measures

Primary Outcome Measures

Potential positive cerebral effects generated by an increase in cerebral blood flow after TAVI [Change from baseline (pre-tavi) to 3 months]
Cerebral blood flow (mL/100g/min, change in %, relative to baseline) as measured on arterial spin labelling magnetic resonance imaging)
Potential negative cerebral outcomes as a consequence of TAVI induced cerebral embolization [Change from baseline (pre-tavi) to 3 months]
New white matter hyperintensities (number and volume [mL]) and (micro) bleeds

Secondary Outcome Measures

Cognitive functioning [Change from baseline (pre-tavi) to 3 months]
Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.
Cognitive functioning [1 year]
Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.
Cardiac output [Change from baseline (pre-tavi) to 3 months]
Cardiac output (L/min) as measured on echocardiography (LVOT VTI)
Cardiac output [1 year]
Cardiac output (L/min) as measured on echocardiography (LVOT VTI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Severe aortic valve stenosis (aortic valve area <1cm2 and/or mean aortic valve gradient exceeds 50 mmHg) of a native valve
Eligible for TAVI
Able and willing to give informed consent
Age > 18 years