the objectives of the CP-TAVI II 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)…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative
to baseline) and cognitive functioning (extensive testing).
Secondary outcome
Regional differences in changes in CBF after TAVI (Δ ml/min/m3); Identify
patient and procedural characteristics associated with increased cardiac
output, CBF, white matter hyperintensity volume and cognitive functioning ;
incidence and volume of new white matter hyperintensities after TAVI (number
and volume mm3, relative increase %); aortic valve calcification volume (mm3),
measured with computed tomography
Background summary
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 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.
Study objective
the objectives of the CP-TAVI II 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 (WMH) TAVI; 2B) evaluate
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.
Study design
Prospective observational study, measuring cardiac output (routine
echocardiography), cerebral blood flow (arterial spin labelling magnetic
resonance imaging) and cognitive functioning (neuropsychologist) prior to TAVI
(<24 hours) and at 3 month follow-up
Study burden and risks
In addition to usual treatment, patients will undergo an MRI scan (30 minutes),
and multiple cognitive tests (90 minutes). The first set of these three tests
will be done during standard admission 24 hours prior to TAVI and the second
set will be done during routine follow-up outpatient appointment. Additional
hospital visits are not needed.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• Presence of severe aortic valve stenosis (aortic valve area < 1 cm2 and/or
mean aortic valve gradients exceeds 50 mmHg) of a native valve
• Be able and willing of giving informed consent
• Eligible for transfemoral TAVI
• Age >18 years
Exclusion criteria
• Presence of a magnetic resonance imaging (MRI) contra-indication.
• Orthopnea or inability to lay flat for 30 minutes
• Bodyweight >130 kg
• Neurological disease
• Insufficient mastery of the Dutch language
• Alcohol use >3 units per day or inability to withdraw 24 hours.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL72247.018.19 |