Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

• Conditions: Cognitive Impairment; Cognitive Change; Aortic Valve Stenosis

• Registration Number: NCT05481008
• Lead Sponsor: Ronak Delewi

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-28
• Study First Submitted: 2022-04-11
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2022-11
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

Exclusion Criteria

• Presence of MRI contra-indication; inability to lay flat for 30 minutes
• Weight > 130 kg
• Neurological disease
• Active malignant disease;
• Insufficient mastery of the Dutch language
• Inability to withdraw from alcohol use for 24 hours
• Non-atherosclerotic vascular disease (eg vasculitis)
• Planned surgery with general anesthesia within three months after TAVI.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
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	1 year	Cardiac output (L/min) as measured on echocardiography (LVOT VTI)

Trial Locations

Locations (1)

Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands