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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 \
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve implantation | Device | All subjects undergo transcatheter aortic valve implantation because of symptomatic severe aortic valve stenosis. This is a routine medical procedure, not a study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cognitive functioning |
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Inclusion Criteria:
Exclusion Criteria:
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N=142 patients with symptomatic severe aortic valve stenosis selected for transcatheter aortic valve implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid van Nieuwkerk, MD | Contact | 0031205666603 | a.vannieuwkerk@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC | Recruiting | Amsterdam | North Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37910335 | Derived | van Nieuwkerk AC, Hemelrijk KI, Bron EE, Leeuwis AE, Majoie CBLM, Daemen MJAP, Moonen JEF, de Sitter A, Bouma BJ, van der Flier WM, Baan J, Piek JJ, Biessels GJ, Delewi R; Heart-Brain Connection Consortium. Cardiac output, cerebral blood flow and cognition in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation: design and rationale of the CAPITA study. Neth Heart J. 2023 Dec;31(12):461-470. doi: 10.1007/s12471-023-01826-8. Epub 2023 Nov 1. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Cognitive functioning on various domains. As measured by a standardized extensive neuropsychological test battery (60-90 minutes) performed by a trained neuropsychologist. |
| 1 year |
| Cardiac output | Cardiac output (L/min) as measured on echocardiography (LVOT VTI) | Change from baseline (pre-tavi) to 3 months |
| Cardiac output | Cardiac output (L/min) as measured on echocardiography (LVOT VTI) | 1 year |
| D014694 |
| Ventricular Outflow Obstruction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |