After TAVI, cardiac output will increase, which leads to increased cerebral blood flow (CBF) and subsequently to improved cognitive functioning. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these…
ID
Bron
Verkorte titel
Aandoening
aortic valve stenosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive testing).
Achtergrond van het onderzoek
Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with increased cerebral blood flow. We hypothesize 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. Therefore we assess 1A) whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) regional differences in CBF after TAVI; 1C) whether (global or regional) increased CBF is associated with improved cognitive functioning; 1D) patient and procedural characteristics associated with increased cardiac output, CBF and cognitive functioning; 2A) the incidence and volume of new white matter hyperintensities (WMH) after TAVI; 2B) patient and procedural predictors for the increase in WMH 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. In a prospective observational cohort of 142 patients undergoing TAVI, we measure cardiac output using inert gas rebreathing; cerebral blood flow using arterial spin labelling MRI; and cognitive functioning using a neuropsychological test battery, prior to TAVI (<24 hours) and at 3 months follow-up.
Doel van het onderzoek
After TAVI, cardiac output will increase, which leads to increased cerebral blood flow (CBF) and subsequently to improved cognitive functioning. 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.
Onderzoeksopzet
Baseline (<24 hours before TAVI) and follow-up 3 months after TAVI
Onderzoeksproduct en/of interventie
Transcatheter aortic valve implantation (TAVI)
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Severe aortic valve stenosis (aortic valve area <1cm2 and/or mean aortic valve gradient exceeds 50 mmHg) of a native valve; able and willing to give informed consent; eligible for transfemoral TAVI, age > 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Presence of MRI contra-indication; inability to lay flat for 30 minutes; weight > 130 kg; neurological presence; active malignant disease; insufficient mastery of the Dutch language; alcohol use inability to withdraw 24 hours; non-atherosclerotic vascular disease (eg vasculitis).
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL8721 |
Ander register | METC AMC : METC 2019_08, NL72247.018.19 |