A Case-control Study of Independent Predictors of Middle Cerebral Artery Aneurysm.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations.
时间窗: from 16 June 2015 to 15 June 2017
CTA scans in DICOM format will be used to create three-dimensional (3D) models of MCA bifurcation using Mimics Innovation Suite platform (Materialise, Leuven, Belgium). The points including the largest curvature of MCA main trunk and two post-bifurcations branches will be automatically calculated according to the centreline fitted with a computer-aided design (CAD) tool. In these points the cross-sectional area (mm2) of the MCA trunk and its two post-bifurcation branches will be calculated automatically.
Computed tomography angiography (CTA) analysis of the best fit diameter of the MCA bifurcations.
时间窗: from 16 June 2015 to 15 June 2017
CTA scans in DICOM format will be used to create three-dimensional (3D) models of MCA bifurcation using Mimics Innovation Suite platform (Materialise, Leuven, Belgium). The points including the largest curvature of MCA main trunk and two post-bifurcations branches will be automatically calculated according to the centreline fitted with a computer-aided design (CAD) tool. In these points the best fit diameter (mm) of the MCA trunk and its two post-bifurcation branches will be calculated automatically.
Computed tomography angiography (CTA) analysis of the angles between the MCA bifurcations components.
时间窗: from 16 June 2015 to 15 June 2017
CTA scans in DICOM format will be used to create three-dimensional (3D) models of MCA bifurcation using Mimics Innovation Suite platform (Materialise, Leuven, Belgium). The points of the largest curvature of MCA main trunk and two post-bifurcations branches will be calculated according to the centreline fitted automatically with a computer-aided design (CAD) tool. The centrelines and the largest curvature points will be exported to 3-matic v.9.0 MIS software. Three points of the largest curvatures (the main MCA trunk and two post-bifurcations branches) together with the point of the intersection of both centrelines passing through the main trunk MCA and both branches will determine the arms and the apex of the three angles. The following angle values will be calculated automatically: the angle between the post-bifurcation branches (α angle) and the angles between the MCA trunk and the larger and the smaller branches (β and γ angle).
Pulsatility Index (PI) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)
时间窗: from 16 June 2015 to 15 June 2017
The assessment of blood flow velocities in both MCAs will be performed by transcranial color-coded sonography (TCCS) using a Vivid 3 Pro (GE Healthcare, Chicago, Illinois, USA) equipped with a multi-frequency transcranial probe (1.5-3.6 MHz). For both MCAs the following will be automatically measured: 1. mean blood flow velocity (V) \[cm/s\] 2. peak systolic velocity (Vps) \[cm/s\] 3. end-diastolic velocity (Ved) \[cm/s\] The velocity measurements will be used to calculate in each vessel the pulsatility index (PI), calculated using the following formula: PI=(Vps-Ved)/V
Volume Flow Rate (VFR) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)
时间窗: from 16 June 2015 to 15 June 2017
The assessment of blood flow velocities in both MCAs will be performed by transcranial color-coded sonography (TCCS) using a Vivid 3 Pro (GE Healthcare, Chicago, Illinois, USA) equipped with a multi-frequency transcranial probe (1.5-3.6 MHz). For both MCAs the following will be automatically measured: 1. mean blood flow velocity (V) \[cm/s\] 2. peak systolic velocity (Vps) \[cm/s\] 3. end-diastolic velocity (Ved) \[cm/s\] The velocity measurements will be used to calculate in each vessel the volume flow rate (VFR) using the following formula: VFR=V\*p, where p - a cross-sectional area of the main MCA trunk, calculated from the morphometric analysis
次要结局
未报告次要终点
研究者
Wojciech Kaspera
Principal Investigator
Medical University of Silesia