Middle Cerebral Artery AneurysmMCAANCT03493035
Risk Factors of Middle Cerebral Artery Aneurysm.
An observational study of Middle Cerebral Artery Aneurysm, run by Medical University of Silesia at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Middle Cerebral Artery Aneurysm
- What is being tested?
- Computed tomography angiography (3D CTA) and Transcranial color-coded sonography (TCCS)
- How many people
- 190 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jun 2015to 15 Jun 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 disorders (e.g. neoplastic disease)
- severe heart failure or multi-organ failure
Show all 9Show fewer
- hemodynamically significant internal carotid artery stenosis
- pregnancy
- family history of cerebral aneurysms.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Middle Cerebral Artery Aneurysm
- Being tested
- Computed tomography angiography (3D CTA), Transcranial color-coded sonography (TCCS)
- Keywords
- Middle Cerebral Artery, Cerebral Aneurysm, Transcranial Color-Coded Sonography, Three-Dimensional Computed Tomography Angiography
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Transcranial color-coded sonography (TCCS)Diagnostic test
TCCS was used to assess of hemodynamic parameters of aneurysmal and non-aneurysmal MCA bifurcations.
| Study group | Role | What they receive |
|---|---|---|
| MCA aneurysm group | All patients with unruptured MCA aneurysm diagnosed on three-dimensional computed tomography angiography (3D CTA) and transcranial color-coded sonography (TCCS) . Receives: 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). Receives: Diagnostic Test: Computed tomography angiography (3D CTA); Diagnostic Test: Transcranial color-coded sonography (TCCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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:
- mean blood flow velocity (V) [cm/s]
- peak systolic velocity (Vps) [cm/s]
- 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
Measured: 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:
- mean blood flow velocity (V) [cm/s]
- peak systolic velocity (Vps) [cm/s]
- 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
Measured: from 16 June 2015 to 15 June 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start16 Jun 2015
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Middle Cerebral Artery AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 190 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Kaspera, Medical University of Silesia
- Investigators
- Wojciech Kaspera, MD, PhD, Principal investigator, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493035
- Sponsor's protocol ID
- SilesianMUNch1
- Acronym
- MCAA
- Status last verified
- Feb 2019
- First submitted
- 5 Jan 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
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.
PubMed 15255260Bor 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.
PubMed 18299521Rossitti S. Shear stress in cerebral arteries carrying saccular aneurysms. A preliminary study. Acta Radiol. 1998 Nov;39(6):711-7. doi: 10.3109/02841859809175503.
PubMed 9817048Kaspera 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.
PubMed 25169949Tutuncu 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.
PubMed 25280096Baharoglu 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.
PubMed 25116869Can 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.
PubMed 25734323Sasaki 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.
PubMed 30137458
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of Independent Predictors of Middle Cerebral Artery Aneurysm.
- ClinicalTrials.gov ID
- NCT03493035
- Acronym / sponsor ID
- MCAA / SilesianMUNch1
- Conditions
- Middle Cerebral Artery Aneurysm
- Keywords
- Middle Cerebral Artery, Cerebral Aneurysm, Transcranial Color-Coded Sonography, Three-Dimensional Computed Tomography Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCA aneurysm group | – | Diagnostic Test: Computed tomography angiography (3D CTA), Diagnostic Test: Transcranial color-coded sonography (TCCS)All patients with unruptured MCA aneurysm diagnosed on three-dimensional computed tomography angiography (3D CTA) and transcranial color-coded sonography (TCCS) . |
| non-MCA aneurysm group | – | Diagnostic Test: Computed tomography angiography (3D CTA), Diagnostic Test: Transcranial color-coded sonography (TCCS)All patients with no evidence of intracranial pathologies on 3D CTA and diagnosed on transcranial color-coded sonography (TCCS). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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 disorders (e.g. neoplastic disease)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography angiography (3D CTA)CTA scans data in DICOM format was used to morphometric analysis of aneurysmal and non-aneurysmal MCA bifurcations. | Diagnostic test | MCA aneurysm group, non-MCA aneurysm group |
| Transcranial color-coded sonography (TCCS)TCCS was used to assess of hemodynamic parameters of aneurysmal and non-aneurysmal MCA bifurcations. | Diagnostic test | MCA aneurysm group, non-MCA aneurysm group |
Primary outcome
Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Results publication: PubMed 15255260Ingebrigtsen 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.
- Results publication: PubMed 18299521Bor 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.
- Results publication: PubMed 9817048Rossitti S. Shear stress in cerebral arteries carrying saccular aneurysms. A preliminary study. Acta Radiol. 1998 Nov;39(6):711-7. doi: 10.3109/02841859809175503.
- Results publication: PubMed 25169949Kaspera 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.
- Results publication: PubMed 25280096Tutuncu 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.
- Results publication: PubMed 25116869Baharoglu 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.
- Results publication: PubMed 25734323Can 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.
- Results publication: PubMed 30137458Sasaki 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Kaspera, MD, PhD principal investigator
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Middle Cerebral Artery Aneurysm, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed tomography angiography (CTA) analysis of the cross-sectional area of the MCA bifurcations. (time frame: from 16 June 2015 to 15 June 2017). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03493035, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.