Middle Cerebral Artery Aneurysm Clinical Trial
Official title:
A Case-control Study of Independent Predictors of Middle Cerebral Artery Aneurysm.
According to the current view, cerebral aneurysms are acquired degenerative lesions resulting from hemodynamic stress. This single-center case-control study will be carried out at the Department of Neurosurgery, Regional Hospital in Sosnowiec, Medical University of Silesia in Katowice, Poland between June 2015 and June 2017. The aim of the study is to determine morphometric and hemodynamic parameters of aneurysmal and non-aneurysmal middle cerebral artery (MCA) bifurcations and to analyze their relationship with aneurysm formation. A minimum of 75 cases and 75 age- and sex-matched controls will be required for the study. Characteristics of the MCA bifurcations will be determined with computed tomography angiography (CTA) and transcranial color-coded sonography (TCCS). The following variables will be evaluated as potential risk factors for MCA aneurysm formation: radii and cross-sectional area of the main MCA trunk and its branches, tortuosity of MCA trunk, asymmetry ratio, area ratio, the angle between the post-bifurcation branches, the angles between the MCA trunk and the larger and smaller branch, volume flow rate, mean flow velocity and pulsatility index of the MCA. All morphometric and hemodynamic parameters will be assessed as potential risk factors for MCA aneurysm formation.
Current evidence suggests that a principal factor involved in formation, enlargement and
rupture of cerebral aneurysms are hemodynamic forces acting at arterial bifurcation. The
objective of this case-control study is to determine morphometric and hemodynamic parameters
of aneurysmal and non-aneurysmal MCA bifurcations and to analyze their relationship with
aneurysm formation. This single-center case-control study will be carried out at the
Department of Neurosurgery, Regional Hospital in Sosnowiec, Medical University of Silesia in
Katowice, Poland between June 2015 and June 2017. The study will include patients (cases)
with unruptured MCA aneurysm diagnosed on three-dimensional computed tomography angiography
(3D CTA). The controls will be patients with no evidence of intracranial pathologies on 3D
CTA, referred to establish the etiology of minor symptoms, such as headache or vertigo. A
minimum of 75 cases and 75 age- and sex-matched controls will be required for the study.
CTA scans data in DICOM format will be transferred to Mimics Innovation Suite (MIS) platform
(Materialise, Leuven, Belgium). Image segmentation and creation of three-dimensional (3D)
models will be carried out with Mimics v.17.0 MIS software (Materialise, Leuven, Belgium).
The segmentation process will include main trunks of the MCA and the post-bifurcation
branches. Trifurcations of the main MCA trunk will be excluded from the morphometric
analysis. MCA bifurcations from the aneurysm patients will be divided into two groups: the An
group with aneurysmal MCA bifurcations and the non-An group with contralateral non-aneurysmal
MCA bifurcations. Also, MCA bifurcations from the controls will be divided into two groups:
R-MCA group with bifurcations of the right MCA and the L-MCA group with bifurcations of the
left MCA. Morphometric analysis will include the following parameters: radii and
cross-sectional area of the main MCA trunk and its branches (for the larger and smaller
branch, respectively), tortuosity of MCA trunk, asymmetry ratio, area ratio, the angle
between the post-bifurcation branches, the angles between the MCA trunk and the larger and
smaller branch. All TCCS examinations will be performed using a Vivid 3 Pro (GE Healthcare,
Chicago, Illinois, USA) equipped with a multi-frequency transcranial probe (1.5-3.6 MHz).
Angle-corrected mean blood flow velocity, peak systolic velocity and end-diastolic velocity
will be measured for both MCAs. Pulsatility index and volume flow rate in each vessel will be
calculated as well. The protocol of the study was approved by the Institutional Review Board,
and written informed consent will be sought from all the study participants. All morphometric
and hemodynamic parameters will be assessed as potential risk factors for MCA aneurysm
formation.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05161377 -
Middle Cerebral Artery Aneurysm Trial
|
N/A | |
| Recruiting |
NCT04927520 -
Prospective, Multicenter Cohort Study on the Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms
|