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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Definition and recruitment of cases The study will include patients (further referred to as cases) with unruptured MCA aneurysm diagnosed on three-dimensional computed tomography angiography (3D CTA).
Case inclusion criteria
* all patients with unruptured MCA aged between 18-75 years Case exclusion criteria
* 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.
Inclusion criteria for the controls
* all patients aged between 18-75 years with no evidence of intracranial pathologies on 3D CTA Exclusion criteria for the controls
* 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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations.
Timeframe: from 16 June 2015 to 15 June 2017
2
Computed tomography angiography (CTA) analysis of the best fit diameter of the MCA bifurcations.
Timeframe: from 16 June 2015 to 15 June 2017
3
Computed tomography angiography (CTA) analysis of the angles between the MCA bifurcations components.
Timeframe: from 16 June 2015 to 15 June 2017
4
Pulsatility Index (PI) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)
Timeframe: from 16 June 2015 to 15 June 2017
5
Volume Flow Rate (VFR) as calculated from transcranial color-coded sonography (TCCS) blood flow velocities (cm/s)