The primary aim of this study is to evaluate the added value of hemodynamics for multi-factorial rupture risk assessment of intracranial aneurysms. The secondary aim is to build a statistical model that can best predict aneurysm rupture taking into…
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Study parameters: 1) MRI measurements of flow velocity (in cm/s) in blood
vessels proximal and distal of intracranial aneurysms. 2) Development of
patient-specific hemodynamic models using CFD. 3) Geometrical data acquired
through 3D rotational angiography.
Endpoints: 1) The influence of the 4 geometric and 4 hemodynamic parameters on
aneurysm rupture status. 2) The relative contribution of the individual
parameters (all parameters as independents) in predicting aneurysm rupture
status (dependent), 3) Selection of parameters to build models in which
aneurysm rupture can be best predicted.
Secondary outcome
Secundary study parameters: development of patient-specific hemodynamic models
using CFD
Secundary outcome: selection of characteristics to build models in which
aneurysm rupture can be best predicted.
Background summary
Intracranial aneurysms are fairly common in the general population. Although
most aneurysms go undetected, acute rupture resulting in subarachnoid
hemorrhage (SAH) can be a devastating consequence associated with high
morbidity and mortality rates. Indication for preventive treatment of
unruptured aneurysms is, however, often not straightforward. The risk of
treatment has to be carefully balanced against the risk of rupture.. At
present, rupture risk assessment of unruptured intracranial aneurysms and the
decision to treat or not is mainly based on size and location of the aneurysm.
It is however clear that the predictive value of these characteristics is
limited. Previous studies found associations between hemodynamic features and
aneurysm rupture using computational fluid dynamics (CFD). However, a limiting
factor of CFD is insufficient knowledge of patient-specific boundary
conditions. In particular, lack of high-fidelity, patient specific, flow-
velocity measurements has hampered the study of hemodynamics of intracranial
aneurysms. Furthermore, the added value of hemodynamics as compared to clinical
and other imaging parameters is still unclear at present.
Study objective
The primary aim of this study is to evaluate the added value of hemodynamics
for multi-factorial rupture risk assessment of intracranial aneurysms. The
secondary aim is to build a statistical model that can best predict aneurysm
rupture taking into account not only clinical parameters and aneurysm
morphology but also hemodynamic parameters of the aneurysm and surrounding
vessels.
Study design
In this prospective, multicenter, matched case-control study, 84 recruited
patients with ruptured (group 1) and 84 patients with unruptured aneurysms
(group 2) will undergo 3D Rotational Angiography (3DRA) and flow velocity
measurements. Hemodynamic features will be generated from both modalities using
CFD. Patientgroups will be matched for age and gender. Patient population and
facilities are present and accessible. 4 morphological parameters (size, aspect
ratio, shape and location of the aneurysm) will be assessed from 3DRA and 4
hemodynamic parameters (average and maximal aneurysm wall shear stress, jet
size, size of impingement zone and flow pattern classification) will be
assessed from the CFD models of all participating patients. Univariate analysis
will be performed to explore the influence of each characteristic on aneurysm
rupture status. Multivariate logistic regression analysis will be performed to
assess the relative contribution of the individual parameters in predicting
aneurysm rupture status.
Study burden and risks
Patients with unruptured aneurysms undergo an MR-scan, which takes 45 minutes
and poses no additional risk to the patient. In patients with a ruptured
aneurysm, the standard clinical practice is that they undergo a follow-up MR
scan 6 months after treatment, to evaluate the occlusion status of the coiled
aneurysm. The flow velocity measurements will be performed during this scan
session, this will increase the duration of the scan with 30 minutes, to a
total of 45 minutes, but poses no additional risk to the patient. 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.
NL
NL
Listed location countries
Age
Inclusion criteria
-patients with ruptured aneurysms, who received an endovascular treatment in one of the participating centers, between August 1st 2008 and December 1st 2010.
-patients with unruptured and untreated aneurysms, whose aneurysms where found incidentally in one of the participating centers
-patients with an aneurysm who underwent a 3D rotational angiography as part of the standard clinical care.
-age between 18-75
-Glasgow Outcome Score(GOS) full recovery/ moderate disability
-written informed consent
Exclusion criteria
Contraindications for MRI (pacemakers, claustrophobia etc. )
previous surgical treatment of an aneurysm with neurosurgical clips
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 | NL25198.018.08 |