The primary aim of this project is to compare measurements of flow velocity in parent and side branch vessels of intracranial aneurysms of ComboWire® with 4D phase-contrast MRA. We will assess the usefulness and accuracy of the 4D MRA for this aim.…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
- measurement of flow velocities (in cm/s) in blood vessels proximal and distal
of intracranial aneurysms as well as within the aneurysms. Flow velocities will
be derived from invasive endovascular measurements using the ComboWire® and
from non-invasive 4D phase-contrast MRA measurements.
- measurements of pressure (mmHg) in blood vessels surrounding intracranial
aneurysms and within the aneurysm, using ComboWire®.
Primary outcome:
- Comparisons of flow velocity measurements in individual patients between
invasive and non-invasive techniques to assess the accuracy of 4D
phase-contrast MRA in measuring flow velocity.
Secondary outcome
Secondary study parameters:
- Measurement of the aneurysm wall displacement on 3DRA and 4D MRA images.
- Visual scores and quantative measurements of aneurysm morphology by two
neuroradiologists based on 3DRA imaging and Maximum Intensity Projection (MIP)
MRA images.
Secondary outcome:
- The construction of a computational model of aneurysm wall elasticity based
on pressure measurements and aneurysm wall distensibility.
- The determination of a relation between aneurysm morphology and its local
flow velocity and pressure.
- Modelling of local hemodynamics of intracranial aneurysms.
Background summary
Intracranial aneurysms are relatively common in the general population and can
lead to moderate to severe disease when ruptured. Treatment of an unruptured
aneurysm may be necessary dependent on the risk of rupture. Risk assessment is
currently based on morphology and size of the aneurysm, but the predictive
value of these characteristics is limited. Hemodynamic stress is considered to
be one of the most important contributing factors to aneurysmal growth and
rupture. Hemodynamic profiles have been predicted using computated models, but
are dependent on several assumptions. Developing possibilities to accurately
measure local hemodynamics in adjacent vessels and within the aneurysm,
preferable non-invasively, will contribute to a better understanding and better
assessment of risk of rupture of an intracranial aneurysm.
Study objective
The primary aim of this project is to compare measurements of flow velocity in
parent and side branch vessels of intracranial aneurysms of ComboWire® with 4D
phase-contrast MRA. We will assess the usefulness and accuracy of the 4D MRA
for this aim. Measurements will be analyzed based on simple mechanic models and
related to the functional regulation of the cerebral circulation. The secondary
aim is to assess aneurysm wall elasticity using pressure measurements in
vessels adjacent to and within intracranial aneurysms obtained by the
ComboWire® and visualized vessel wall distension on MRA/ 3-dimentional
Rotational Angiography (3DRA). The geometry and ComboWire® data may lead to
more detailed theoretic models of local flow and pressure distribution in
adjacent vessels and within the aneurysm.
Study design
A single-centre, prospective observational Pilot study.
Study burden and risks
Patients undergo an extra MRI-scan, which takes 30 minutes and poses no
additional risk to the patient. During the endovascular treatment procedure the
ComboWire® is used instead of the standard microguidewire, which has comparable
characteristics but prolongs the procedure with 25 minutes, of which a maximum
of 10 minutes extra fluoroscopy time. Patients with unruptured intracranial
aneurysms may benefit from this study in the future. We expect this study to
lead to a better identification of the *vulnerable aneurysm*, providing a
better indication for preventive treatment.
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
Nederland
Meibergdreef 9, postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with untreated unruptured aneurysms in or near the circle of Willis, found incidentally, in screening populations or in patients with multiple aneurysms
- Planned for endovascular treatment at the AMC
- Age 18- 70 yrs
- Written informed consent
Exclusion criteria
contrast allergy, impared renal function, contra-indications for MRI (pacemaker, claustrofobia, etc.)
Design
Recruitment
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 | NL18748.018.07 |