Risk Factors of Middle Cerebral Artery Aneurysm.

NCT03493035 | Completed

• 1 other identifier: SilesianMUNch1
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Middle Cerebral Artery Aneurysm

Keywords

Middle Cerebral Artery; Cerebral Aneurysm; Transcranial Color-Coded Sonography; Three-Dimensional Computed Tomography Angiography

Outcome Measures

Primary Outcomes (5)

• Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations.

  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.

  from 16 June 2015 to 15 June 2017

• Computed tomography angiography (CTA) analysis of the best fit diameter of the MCA bifurcations.

  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.

  from 16 June 2015 to 15 June 2017

• Computed tomography angiography (CTA) analysis of the angles between the MCA bifurcations components.

  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).

  from 16 June 2015 to 15 June 2017

• Pulsatility Index (PI) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)

  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

  from 16 June 2015 to 15 June 2017

• Volume Flow Rate (VFR) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)

  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

  from 16 June 2015 to 15 June 2017

Study Arms (2)

MCA aneurysm group

All patients with unruptured MCA aneurysm diagnosed on three-dimensional computed tomography angiography (3D CTA) and transcranial color-coded sonography (TCCS) .

Diagnostic Test: Computed tomography angiography (3D CTA); Diagnostic Test: Transcranial color-coded sonography (TCCS)

non-MCA aneurysm group

All patients with no evidence of intracranial pathologies on 3D CTA and diagnosed on transcranial color-coded sonography (TCCS).

Diagnostic Test: Computed tomography angiography (3D CTA); Diagnostic Test: Transcranial color-coded sonography (TCCS)

Interventions

Computed tomography angiography (3D CTA) DIAGNOSTIC_TEST

CTA scans data in DICOM format was used to morphometric analysis of aneurysmal and non-aneurysmal MCA bifurcations.

MCA aneurysm group; non-MCA aneurysm group

Transcranial color-coded sonography (TCCS) DIAGNOSTIC_TEST

TCCS was used to assess of hemodynamic parameters of aneurysmal and non-aneurysmal MCA bifurcations.

MCA aneurysm group; non-MCA aneurysm group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients (further referred to as 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.

You may not qualify if:

• refusal to participate in the study
• inability to give informed consent
• presence of multiple cerebral aneurysms
• presence of pathologies, other than MCA aneurysm, in the central nervous system that could have a potential effect on cerebral blood flow (e.g. ischemic stroke, intracerebral or subarachnoid hemorrhage)
• severe systemic disorders (e.g. neoplastic disease)
• severe heart failure or multi-organ failure
• hemodynamically significant internal carotid artery stenosis
• pregnancy
• family history of cerebral aneurysms.
• Definition and recruitment of controls 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.
• refusal to participate in the study
• inability to give informed consent
• presence of pathologies in the central nervous system that could have a potential effect on cerebral blood flow (e.g. ischemic stroke, intracerebral or subarachnoid hemorrhage)
• severe systemic disorders (e.g. neoplastic disease)
• severe heart failure or multi-organ failure

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Wojciech Kaspera

Sosnowiec, Smorzykk@gmail.com, 41-200, Poland

Location

Related Publications (8)

• Ingebrigtsen T, Morgan MK, Faulder K, Ingebrigtsen L, Sparr T, Schirmer H. Bifurcation geometry and the presence of cerebral artery aneurysms. J Neurosurg. 2004 Jul;101(1):108-13. doi: 10.3171/jns.2004.101.1.0108.

  PMID: 15255260 RESULT

• Bor AS, Velthuis BK, Majoie CB, Rinkel GJ. Configuration of intracranial arteries and development of aneurysms: a follow-up study. Neurology. 2008 Feb 26;70(9):700-5. doi: 10.1212/01.wnl.0000302176.03551.35.

  PMID: 18299521 RESULT

• Rossitti S. Shear stress in cerebral arteries carrying saccular aneurysms. A preliminary study. Acta Radiol. 1998 Nov;39(6):711-7. doi: 10.3109/02841859809175503.

  PMID: 9817048 RESULT

• Kaspera W, Ladzinski P, Larysz P, Hebda A, Ptaszkiewicz K, Kopera M, Larysz D. Morphological, hemodynamic, and clinical independent risk factors for anterior communicating artery aneurysms. Stroke. 2014 Oct;45(10):2906-11. doi: 10.1161/STROKEAHA.114.006055. Epub 2014 Aug 28.

  PMID: 25169949 RESULT

• Tutuncu F, Schimansky S, Baharoglu MI, Gao B, Calnan D, Hippelheuser J, Safain MG, Lauric A, Malek AM. Widening of the basilar bifurcation angle: association with presence of intracranial aneurysm, age, and female sex. J Neurosurg. 2014 Dec;121(6):1401-10. doi: 10.3171/2014.8.JNS1447. Epub 2014 Oct 3.

  PMID: 25280096 RESULT

• Baharoglu MI, Lauric A, Safain MG, Hippelheuser J, Wu C, Malek AM. Widening and high inclination of the middle cerebral artery bifurcation are associated with presence of aneurysms. Stroke. 2014 Sep;45(9):2649-55. doi: 10.1161/STROKEAHA.114.005393. Epub 2014 Aug 12.

  PMID: 25116869 RESULT

• Can A, Ho AL, Dammers R, Dirven CM, Du R. Morphological parameters associated with middle cerebral artery aneurysms. Neurosurgery. 2015 Jun;76(6):721-6; discussion 726-7. doi: 10.1227/NEU.0000000000000713.

  PMID: 25734323 RESULT

• Sasaki T, Kakizawa Y, Yoshino M, Fujii Y, Yoroi I, Ichikawa Y, Horiuchi T, Hongo K. Numerical Analysis of Bifurcation Angles and Branch Patterns in Intracranial Aneurysm Formation. Neurosurgery. 2019 Jul 1;85(1):E31-E39. doi: 10.1093/neuros/nyy387.

  PMID: 30137458 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Wojciech Kaspera, MD, PhD

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: April 10, 2018
• Study Start: June 16, 2015
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available for 5 years after study completion.
• Access Criteria: Data will be shared electronically by email or by depositing on a secure file share server depending on file type and size. If necessary, non-confidential files will be supplied on a data CD or USB flash drive. When requested, the data will be made available by the PI provided the request does not interfere with publication, compromise intellectual property interests, or precede data analysis. The data acquired and preserved will be governed by Medical University of Silesia policies regarding intellectual property, record retention, and data management.

Locations

PL (1)