Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

Cognitive Impairment Clinical Trial

— CAPITA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481008
• Other study ID #: NL72247.018.19
• Status: Recruiting
• Start date: August 28, 2020
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Astrid van Nieuwkerk, MD
• Phone: 0031205666603
• Email: a.vannieuwkerk[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: August 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cognitive Change
• Cognitive Dysfunction
• Cognitive Impairment
• Constriction, Pathologic

Intervention

Device:
• transcatheter aortic valve implantation
All subjects undergo transcatheter aortic valve implantation because of symptomatic severe aortic valve stenosis. This is a routine medical procedure, not a study intervention.

Locations

Country	Name	City	State
Netherlands	Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Ronak Delewi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential positive cerebral effects generated by an increase in cerebral blood flow after TAVI	Cerebral blood flow (mL/100g/min, change in %, relative to baseline) as measured on arterial spin labelling magnetic resonance imaging)	Change from baseline (pre-tavi) to 3 months
Primary	Potential negative cerebral outcomes as a consequence of TAVI induced cerebral embolization	New white matter hyperintensities (number and volume [mL]) and (micro) bleeds	Change from baseline (pre-tavi) to 3 months
Secondary	Cognitive functioning	Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.	Change from baseline (pre-tavi) to 3 months
Secondary	Cognitive functioning	Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist.	1 year
Secondary	Cardiac output	Cardiac output (L/min) as measured on echocardiography (LVOT VTI)	Change from baseline (pre-tavi) to 3 months
Secondary	Cardiac output	Cardiac output (L/min) as measured on echocardiography (LVOT VTI)	1 year