@neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms (@neurIST)

@neurIST : Informatique biomédicale intégrée Pour la Gestion Des anévrismes cérébraux

The primary aim of the SwissNeuroFoundation AneurysmDataBase Project is to implement information technology based tools to create and use a holistic reference database specific to intracranial aneurysms (IA).

The SwissNeuroFoundation AneurysmDataBase are concerned with generating the data with which to populate this database.

The purpose for populating the database are to:

• Screen for and evaluate markers of risk for intracranial aneurysm formation and aneurysm rupture. Are considered as markers the following: genetics factors, microbiota, environmental factors, congenital factors (ie: cerebrovascular anatomical variants), transcriptomics signature, proteomics signature,shape characteristics, haemodynamics characteristics.
• Screen for and evaluate prognostic factors of outcome regarding different management strategies including watchful observation, microsurgical treatment, endovascular treatment or any combination thereof.
• Implement and evaluate patient-specific management protocols integrating all available information.
• Evaluate the impact of the database and use of tools to improve care, reduce costs, support knowledge discovery and promote new industrial developments.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm

Detailed Description

Clinical history, imaging data, biological samples and information derived from are the main items to be captured to the SwissNeuroFoundation AneurysmDataBase. No limits are set on the number of healthy volunteers and patient cases for whom data can be entered to the SwissNeuroFoundation AneurysmDataBase.

Participants will be recruited from the following sources:

• Patients arriving at partner clinical centers either as newly diagnosed (incidental cases) or already known for the disease (prevalent cases)
• Healthy volunteers answering a call, randomly selected subjects from a known population that consent to participate or non genetically linked family members of patients that consent to participate
• Family members of patients identified as having a familial history of intracranial aneurysm (IA).

Points of consent:

The specific items on which participants are asked to consent:

• to having been verbally informed of the aims of the project
• to having read the information sheet about the project, been able to ask questions about the project, and to having received satisfactory answers and enough time to make the decision.
• to having been informed that any damage that could be directly caused by the participation to the project is covered by insurance.
• that hospital care providers working on behalf of the project and representatives of the local authorities and ethics commission may access in a strictly confidential term raw data for quality check.
• to having been informed that participation can be withdrawn anytime without justification and will result in a medical assessment for own security. There will be no impact on future care resulting from withdrawal.
• to be free to refuse answering questions without requiring any justification and it will have no impact on future care.
• to understand that data may be used in a non-identifying form for publication.
• to understand that data provided may form part of future commercial applications, and will not benefit financially from this.
• to understand and agree that coded data may be used for further cerebrovascular-related research.
• that they understand that coded data about them or biological samples may be transferred outside the European Union.

The specific items on which participants are asked to agree or disagree:

• that they agree to provide access to health records, to provide a link from them to the SwissNeuroFoundation AneurysmDataBase, and to complete a questionnaire on their clinical history.
• give agreement to provide image data to SwissNeuroFoundation AneurysmDataBase.
• give agreement to provide blood samples to SwissNeuroFoundation AneurysmDataBase.
• give agreement to use biological samples resulting from therapeutical intervention.
• give agreement to use saliva and stool samples to SwissNeuroFoundation AneurysmDataBase.
• give agreement to be re-contacted by SwissNeuroFoundation AneurysmDataBase for further consent or to request further information.
• give agreement to inform the General Practitioner about the participation to the project.
• give agreement to contact the General Practitioner to request information on participant whereabouts or limited relevant medical information, if direct contact was unsuccessful during 3 months.
• request to be informed by the clinician in charge about observations resulting from the project that may have a significant impact on the participant health.
• request the General Practitioner of the participant to be informed about observations resulting from the project that may have a significant impact on the participant health.

Separate specific points of consent relative to biological samples and genetics:

• having read the genetic testing information sheet, been able to ask questions about genetic testing, and understanding why the research is being done and any risks involved
• give agreement to provide blood samples to SwissNeuroFoundation AneurysmDataBase
• understanding that genetic data arising from samples may form part of future commercial applications, and that they will not benefit financially from this.
• understanding that they are free to withdraw at any time and may ask for their sample to be destroyed then, or at any other time.
• agree that blood samples be stored and used for genetic analysis.
• agree that blood, aneurysm dome, cerebrospinal fluid (CSF) and microdialysis samples be stored and used for further cerebrovascular-related research.
• agreement that blood samples may be transferred with coded labels to other Universities in the World.

For the purpose of the AneurysmDataBase:

Clinical Information consists of:

• Demographic information (Pseudonym, Age, Gender, Size, Weight, work and sport activities, habits: smoking, alcool consumption).
• Personal medical history (Previous strokes, previous epilepsy, previous medication)
• Family tree denoting known or likely diagnosed IA or subarachnoid hemorrhage (SAH) events.
• Signs and symptoms (date of ictus, date of diagnosis, mRankin score, Glasgow Coma Scale (GCS), NIH Stroke Scale (NIHSS),Mini Mental State Exam (MMSE), World Federation of Neurosurgeons Scale WFNS, Cranial nerve deficits)
• Identified epidemiology factors according to check list.
• Imaging analysis (Presence of SAH, Fisher grade, size of ventricles, size of basal cisterns, volume of hematoma and location, number of aneurysms, location of aneurysms, size of aneurysms, shape of aneurysm)
• Treatment and outcome information (treatment method, success)
• Follow-up and outcome information (Quality of life assessment, MMSE, mRankin, NIHSS, Cranial nerve deficits, aneurysms status: stable, growth, treated, partially treated)

Imaging Data consist of:

• Pseudonymised DICOM files of:
• MRI angiography (MRA)
• Computed Tomography Angiography (CTA)
• 3D reconstruction of Digital Rotation Angiography (3D-DRA)

Samples consist of:

• Blood in DNA saving solution
• Blood in RNA saving solution
• Blood in EDTA
• CSF
• Aneurysm dome
• Saliva
• Stool
• Other biological sample to be specified

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Sven Hirsch, Dr; Phone Number: +41 58 934 54 44; Email: hirc@zhaw.ch
• Study Contact Backup: Name: Philippe Bijlenga, PD MD PhD; Phone Number: +41 22 372 34 26; Email: philippe.bijlenga@hcuge.ch

Study Locations

• Canada
  • Montreal, Canada
    • Recruiting
    • Montreal Neurological Institute and Hospital, McGill University
    • Contact: Guy Rouleau
• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Behman Rezai Jahromi
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Antti Lindgren
• France
  • Nantes, France
    • Recruiting
    • ICAN
    • Contact: Romain Bourcier
• Germany
  • Munich, Germany
    • Recruiting
    • Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich
    • Contact: Maria Wostrack
    • Sub-Investigator: Isabel Hostettler
• Hungary
  • Pécs, Hungary
    • Completed
    • University of Pécs
• Netherlands
  • Rotterdam, Netherlands
    • Completed
    • Erasmus Medical Center
  • Utrecht, Netherlands
    • Recruiting
    • University Medical Center Utrecht
    • Contact: Ynte Ruigrok
• Poland
  • Krakow, Poland
    • Recruiting
    • Jagiellonian University Medical College
    • Contact: Joanna Pera
• Spain
  • Barcelona, Spain
    • Completed
    • Barcelona Hospital General de Cataluna
  • Barcelona, Spain
    • Completed
    • Hospital Clinic Barcelona
  • Barcelona, Spain
    • Recruiting
    • IMIM - Hospital del Mar
    • Contact: Jordi Jimenez Corde
• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Neurochirurgie / Hôpitaux Universitaire de Genève
    • Contact: Philippe Bijlenga, PD MD PhD; Phone Number: +41795533772; Email: philippe.bijlenga@hcuge.ch
    • Contact: Karl Schaller, Prof; Phone Number: +41223728201; Email: karl.schaller@hcuge.ch
  • Lausanne, Switzerland, 1011
    • Recruiting
    • University Hospital of Lausanne (CHUV), CoLaus Datacenter
    • Contact: Peter Vollenweider, Prof
  • Sankt Gallen, Switzerland
    • Recruiting
    • Department of Neurosurgery, Cantonal Hospital St. Gallen
    • Contact: Isabel Hostettler
  • Zurich, Switzerland, 8008
    • Not yet recruiting
    • Klinik Hirslanded
    • Contact: Daniel Rüfenacht, Prof; Phone Number: +41 44 387 28 50; Email: daniel.rufenacht@hirslanden.ch
    • Contact: Isabel Wanke, Prof; Phone Number: +41 44 387 28 50; Email: isabel.wanke@hirslanden.ch
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London
    • Contact: David Werring
  • Oxford, United Kingdom
    • Completed
    • Radcliffe Infirmary
  • Sheffield, United Kingdom
    • Completed
    • Royal Hallamshire Hospital
• United States
  • California
    • San Francisco, California, United States
      • Recruiting
      • University of California
      • Contact: Nerissa Ko
  • Ohio
    • Cincinnati, Ohio, United States
      • Recruiting
      • University of Cincinnati College of Medicine
      • Contact: Joseph Broderick
      • Sub-Investigator: Daniel Woo
  • Virginia
    • Virginia Beach, Virginia, United States
      • Recruiting
      • University of Virginia
      • Contact: Bradford Worrall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Prospective consecutive recruitment of cases newly diagnosed intracranial aneurysm in each participating clinical center.

Description

Inclusion Criteria:

• able to provide consent or, in the event that a patient is incapable of providing consent, that a person is legally authorized to do so on behalf of the patient according to legal and ethical requirements of the country where the clinical centre is located.

Patients:

• must have an angiographically proven intracranial aneurysm (MRA< CTA< DSA accepted).The determination of SAH requires the presence of a subarachnoid haemorrhage be verified on CT or by lumbar puncture.

MRA: Magnetic Resonance Angiography CTA: Computed Tomography Angiography DSA: Digital Subtracted Angiography

Exclusion Criteria:

• failure of a candidate to contribute clinical data,
• refusal to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
IA Patients; Patients with one or more identified intracranial aneurysm, none of which are believed to have ruptured.
IA + SAH Patients; Patients with one or more identified intracranial aneurysm, at least one of which has been radiologically or surgically determined to have ruptured.
Familiy members; Individuals selected on review of a patient's family tree and contacted by said patient, who agree to be approached for recruitment. In affected families each member will be identified as: proband, affected, unaffected, unknown, or not genetically linked.
Healthy Volunteers; Individuals, accompanying or contacted by a patient, or responding to open advertisement, or randomly selected in a defined population who agree to be approached for recruitment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease model validation	Validation and improvement of the holistic disease model	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life expectancy	Age at death	20 years
Disability	Disease induced disability on modified Rankin scale and duration of disability	20 years
Cure	Absence of new treatments or bleeding after initial treatment	20 years
Adverse events	Aneurysm rupture after diagnosis or treatment related severe complications	20 years
Aneurysm growth	Observation of the growth of an aneurysm after diagnosis	20 years
Radiological aneurysm exclusion	Ability to completely and permanently exclude the lesion with the treatment	20 years
Recurrence	Recurrence or repermeabilisation of the aneurysm after treatment	20 years
Neo-aneurysm formation	New identification of aneurysm during follow up previously not diagnosed	20 years
Neurological status	regular measurement of the NIHSS during follow-up	20 years
Cranial nerves status	regular evaluation of cranial nerve function during follow-up	20 years
Occurence of hydrocephalus	need for internal CSF drainage system implantation	20 years
Occurence of vasospasm	need for aggressive hypertensive treatment or endo-vascular rescue therapy (IA vasodilator injection, balloon angioplasty)	20 years
Quality of life	regular measurement of quality of life during follow-up (i.e. EQ-5D)	20 years
Neuropsychological performance	regular measurement of neuropsychological performance (i.e. MMSE, MOCA, dedicated evaluation)	20 years
Delayed Cerebral Injury (DCI)	Radiological secondary brain injury associated to vasospasm excluding injuries associated with aneurysm intervention	20 years

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: University of Geneva, Switzerland; Klinik Hirslanden, Zurich
• Investigators: Principal Investigator: Philippe Bijlenga, PD MD PhD, Geneva University; Study Chair: Sandrine Morel, PD PhD, Hôpitaux Universitaire de Genève

Publications and helpful links

General Publications

• Reymond P, Merenda F, Perren F, Rufenacht D, Stergiopulos N. Validation of a one-dimensional model of the systemic arterial tree. Am J Physiol Heart Circ Physiol. 2009 Jul;297(1):H208-22. doi: 10.1152/ajpheart.00037.2009. Epub 2009 May 8.
• Schaap M, Metz CT, van Walsum T, van der Giessen AG, Weustink AC, Mollet NR, Bauer C, Bogunovic H, Castro C, Deng X, Dikici E, O'Donnell T, Frenay M, Friman O, Hernandez Hoyos M, Kitslaar PH, Krissian K, Kuhnel C, Luengo-Oroz MA, Orkisz M, Smedby O, Styner M, Szymczak A, Tek H, Wang C, Warfield SK, Zambal S, Zhang Y, Krestin GP, Niessen WJ. Standardized evaluation methodology and reference database for evaluating coronary artery centerline extraction algorithms. Med Image Anal. 2009 Oct;13(5):701-14. doi: 10.1016/j.media.2009.06.003. Epub 2009 Jun 30.
• Yasuno K, Bilguvar K, Bijlenga P, Low SK, Krischek B, Auburger G, Simon M, Krex D, Arlier Z, Nayak N, Ruigrok YM, Niemela M, Tajima A, von und zu Fraunberg M, Doczi T, Wirjatijasa F, Hata A, Blasco J, Oszvald A, Kasuya H, Zilani G, Schoch B, Singh P, Stuer C, Risselada R, Beck J, Sola T, Ricciardi F, Aromaa A, Illig T, Schreiber S, van Duijn CM, van den Berg LH, Perret C, Proust C, Roder C, Ozturk AK, Gaal E, Berg D, Geisen C, Friedrich CM, Summers P, Frangi AF, State MW, Wichmann HE, Breteler MM, Wijmenga C, Mane S, Peltonen L, Elio V, Sturkenboom MC, Lawford P, Byrne J, Macho J, Sandalcioglu EI, Meyer B, Raabe A, Steinmetz H, Rufenacht D, Jaaskelainen JE, Hernesniemi J, Rinkel GJ, Zembutsu H, Inoue I, Palotie A, Cambien F, Nakamura Y, Lifton RP, Gunel M. Genome-wide association study of intracranial aneurysm identifies three new risk loci. Nat Genet. 2010 May;42(5):420-5. doi: 10.1038/ng.563. Epub 2010 Apr 4.
• Morgan AA, Lu Z, Wang X, Cohen AM, Fluck J, Ruch P, Divoli A, Fundel K, Leaman R, Hakenberg J, Sun C, Liu HH, Torres R, Krauthammer M, Lau WW, Liu H, Hsu CN, Schuemie M, Cohen KB, Hirschman L. Overview of BioCreative II gene normalization. Genome Biol. 2008;9 Suppl 2(Suppl 2):S3. doi: 10.1186/gb-2008-9-s2-s3. Epub 2008 Sep 1.
• Reymond P, Bohraus Y, Perren F, Lazeyras F, Stergiopulos N. Validation of a patient-specific one-dimensional model of the systemic arterial tree. Am J Physiol Heart Circ Physiol. 2011 Sep;301(3):H1173-82. doi: 10.1152/ajpheart.00821.2010. Epub 2011 May 27.
• Bauer-Mehren A, Furlong LI, Sanz F. Pathway databases and tools for their exploitation: benefits, current limitations and challenges. Mol Syst Biol. 2009;5:290. doi: 10.1038/msb.2009.47. Epub 2009 Jul 28.
• Morbiducci U, Kok AM, Kwak BR, Stone PH, Steinman DA, Wentzel JJ. Atherosclerosis at arterial bifurcations: evidence for the role of haemodynamics and geometry. Thromb Haemost. 2016 Mar;115(3):484-92. doi: 10.1160/TH15-07-0597. Epub 2016 Jan 7.
• Augsburger L, Farhat M, Reymond P, Fonck E, Kulcsar Z, Stergiopulos N, Rufenacht DA. Effect of flow diverter porosity on intraaneurysmal blood flow. Klin Neuroradiol. 2009 Aug;19(3):204-14. doi: 10.1007/s00062-009-9005-0. Epub 2009 Aug 23.
• Ribeiro-Rodrigues TM, Martins-Marques T, Morel S, Kwak BR, Girao H. Role of connexin 43 in different forms of intercellular communication - gap junctions, extracellular vesicles and tunnelling nanotubes. J Cell Sci. 2017 Nov 1;130(21):3619-3630. doi: 10.1242/jcs.200667. Epub 2017 Oct 12.
• Reymond P, Crosetto P, Deparis S, Quarteroni A, Stergiopulos N. Physiological simulation of blood flow in the aorta: comparison of hemodynamic indices as predicted by 3-D FSI, 3-D rigid wall and 1-D models. Med Eng Phys. 2013 Jun;35(6):784-91. doi: 10.1016/j.medengphy.2012.08.009. Epub 2012 Sep 12.
• Bijlenga P, Ebeling C, Jaegersberg M, Summers P, Rogers A, Waterworth A, Iavindrasana J, Macho J, Pereira VM, Bukovics P, Vivas E, Sturkenboom MC, Wright J, Friedrich CM, Frangi A, Byrne J, Schaller K, Rufenacht D; @neurIST Investigators. Risk of rupture of small anterior communicating artery aneurysms is similar to posterior circulation aneurysms. Stroke. 2013 Nov;44(11):3018-26. doi: 10.1161/STROKEAHA.113.001667. Epub 2013 Jul 30.
• Larrabide I, Kim M, Augsburger L, Villa-Uriol MC, Rufenacht D, Frangi AF. Fast virtual deployment of self-expandable stents: method and in vitro evaluation for intracranial aneurysmal stenting. Med Image Anal. 2012 Apr;16(3):721-30. doi: 10.1016/j.media.2010.04.009. Epub 2010 May 11.
• Yasuno K, Bakircioglu M, Low SK, Bilguvar K, Gaal E, Ruigrok YM, Niemela M, Hata A, Bijlenga P, Kasuya H, Jaaskelainen JE, Krex D, Auburger G, Simon M, Krischek B, Ozturk AK, Mane S, Rinkel GJ, Steinmetz H, Hernesniemi J, Schaller K, Zembutsu H, Inoue I, Palotie A, Cambien F, Nakamura Y, Lifton RP, Gunel M. Common variant near the endothelin receptor type A (EDNRA) gene is associated with intracranial aneurysm risk. Proc Natl Acad Sci U S A. 2011 Dec 6;108(49):19707-12. doi: 10.1073/pnas.1117137108. Epub 2011 Nov 21.
• Augsburger L, Reymond P, Rufenacht DA, Stergiopulos N. Intracranial stents being modeled as a porous medium: flow simulation in stented cerebral aneurysms. Ann Biomed Eng. 2011 Feb;39(2):850-63. doi: 10.1007/s10439-010-0200-6. Epub 2010 Nov 2.
• Clarke M. Systematic review of reviews of risk factors for intracranial aneurysms. Neuroradiology. 2008 Aug;50(8):653-64. doi: 10.1007/s00234-008-0411-9. Epub 2008 Jun 17.
• Marzo A, Singh P, Larrabide I, Radaelli A, Coley S, Gwilliam M, Wilkinson ID, Lawford P, Reymond P, Patel U, Frangi A, Hose DR. Computational hemodynamics in cerebral aneurysms: the effects of modeled versus measured boundary conditions. Ann Biomed Eng. 2011 Feb;39(2):884-96. doi: 10.1007/s10439-010-0187-z. Epub 2010 Oct 23.
• Larrabide I, Aguilar ML, Morales HG, Geers AJ, Kulcsar Z, Rufenacht D, Frangi AF. Intra-aneurysmal pressure and flow changes induced by flow diverters: relation to aneurysm size and shape. AJNR Am J Neuroradiol. 2013 Apr;34(4):816-22. doi: 10.3174/ajnr.A3288. Epub 2012 Sep 27.
• Morales HG, Kim M, Vivas EE, Villa-Uriol MC, Larrabide I, Sola T, Guimaraens L, Frangi AF. How do coil configuration and packing density influence intra-aneurysmal hemodynamics? AJNR Am J Neuroradiol. 2011 Nov-Dec;32(10):1935-41. doi: 10.3174/ajnr.A2635. Epub 2011 Sep 1.
• Bogunovic H, Pozo JM, Villa-Uriol MC, Majoie CB, van den Berg R, Gratama van Andel HA, Macho JM, Blasco J, Roman LS, Frangi AF. Automated segmentation of cerebral vasculature with aneurysms in 3DRA and TOF-MRA using geodesic active regions: an evaluation study. Med Phys. 2011 Jan;38(1):210-22. doi: 10.1118/1.3515749.
• Watton PN, Raberger NB, Holzapfel GA, Ventikos Y. Coupling the hemodynamic environment to the evolution of cerebral aneurysms: computational framework and numerical examples. J Biomech Eng. 2009 Oct;131(10):101003. doi: 10.1115/1.3192141.
• Geers AJ, Larrabide I, Radaelli AG, Bogunovic H, Kim M, Gratama van Andel HA, Majoie CB, VanBavel E, Frangi AF. Patient-specific computational hemodynamics of intracranial aneurysms from 3D rotational angiography and CT angiography: an in vivo reproducibility study. AJNR Am J Neuroradiol. 2011 Mar;32(3):581-6. doi: 10.3174/ajnr.A2306. Epub 2010 Dec 23.
• Elger BS, Iavindrasana J, Lo Iacono L, Muller H, Roduit N, Summers P, Wright J. Strategies for health data exchange for secondary, cross-institutional clinical research. Comput Methods Programs Biomed. 2010 Sep;99(3):230-51. doi: 10.1016/j.cmpb.2009.12.001. Epub 2010 Jan 20.
• Watton PN, Ventikos Y, Holzapfel GA. Modelling the growth and stabilization of cerebral aneurysms. Math Med Biol. 2009 Jun;26(2):133-64. doi: 10.1093/imammb/dqp001. Epub 2009 Feb 20.
• Kroon M, Holzapfel GA. A new constitutive model for multi-layered collagenous tissues. J Biomech. 2008 Aug 28;41(12):2766-71. doi: 10.1016/j.jbiomech.2008.05.033. Epub 2008 Jul 26.
• Kroon M, Holzapfel GA. A theoretical model for fibroblast-controlled growth of saccular cerebral aneurysms. J Theor Biol. 2009 Mar 7;257(1):73-83. doi: 10.1016/j.jtbi.2008.10.021. Epub 2008 Nov 5.
• Risselada R, Lingsma HF, Bauer-Mehren A, Friedrich CM, Molyneux AJ, Kerr RS, Yarnold J, Sneade M, Steyerberg EW, Sturkenboom MC. Prediction of 60 day case-fatality after aneurysmal subarachnoid haemorrhage: results from the International Subarachnoid Aneurysm Trial (ISAT). Eur J Epidemiol. 2010 Apr;25(4):261-6. doi: 10.1007/s10654-010-9432-x. Epub 2010 Feb 14.
• Marzo A, Singh P, Reymond P, Stergiopulos N, Patel U, Hose R. Influence of inlet boundary conditions on the local haemodynamics of intracranial aneurysms. Comput Methods Biomech Biomed Engin. 2009 Aug;12(4):431-44. doi: 10.1080/10255840802654335.
• Watton PN, Selimovic A, Raberger NB, Huang P, Holzapfel GA, Ventikos Y. Modelling evolution and the evolving mechanical environment of saccular cerebral aneurysms. Biomech Model Mechanobiol. 2011 Feb;10(1):109-32. doi: 10.1007/s10237-010-0221-y. Epub 2010 May 23.
• Geers AJ, Larrabide I, Morales HG, Frangi AF. Approximating hemodynamics of cerebral aneurysms with steady flow simulations. J Biomech. 2014 Jan 3;47(1):178-85. doi: 10.1016/j.jbiomech.2013.09.033. Epub 2013 Nov 1.
• Diagbouga MR, Morel S, Bijlenga P, Kwak BR. Role of hemodynamics in initiation/growth of intracranial aneurysms. Eur J Clin Invest. 2018 Sep;48(9):e12992. doi: 10.1111/eci.12992. Epub 2018 Jul 20.
• Villa-Uriol MC, Berti G, Hose DR, Marzo A, Chiarini A, Penrose J, Pozo J, Schmidt JG, Singh P, Lycett R, Larrabide I, Frangi AF. @neurIST complex information processing toolchain for the integrated management of cerebral aneurysms. Interface Focus. 2011 Jun 6;1(3):308-19. doi: 10.1098/rsfs.2010.0033. Epub 2011 Apr 6.
• Risselada R, Straatman H, van Kooten F, Dippel DW, van der Lugt A, Niessen WJ, Firouzian A, Herings RM, Sturkenboom MC. Withdrawal of statins and risk of subarachnoid hemorrhage. Stroke. 2009 Aug;40(8):2887-92. doi: 10.1161/STROKEAHA.109.552760. Epub 2009 Jun 11.
• Detmer FJ, Luckehe D, Mut F, Slawski M, Hirsch S, Bijlenga P, von Voigt G, Cebral JR. Comparison of statistical learning approaches for cerebral aneurysm rupture assessment. Int J Comput Assist Radiol Surg. 2020 Jan;15(1):141-150. doi: 10.1007/s11548-019-02065-2. Epub 2019 Sep 4.
• Geers AJ, Morales HG, Larrabide I, Butakoff C, Bijlenga P, Frangi AF. Wall shear stress at the initiation site of cerebral aneurysms. Biomech Model Mechanobiol. 2017 Feb;16(1):97-115. doi: 10.1007/s10237-016-0804-3. Epub 2016 Jul 20.
• Pozo JM, Villa-Uriol MC, Frangi AF. Efficient 3D geometric and Zernike moments computation from unstructured surface meshes. IEEE Trans Pattern Anal Mach Intell. 2011 Mar;33(3):471-84. doi: 10.1109/TPAMI.2010.139.
• Reymond P, Perren F, Lazeyras F, Stergiopulos N. Patient-specific mean pressure drop in the systemic arterial tree, a comparison between 1-D and 3-D models. J Biomech. 2012 Oct 11;45(15):2499-505. doi: 10.1016/j.jbiomech.2012.07.020. Epub 2012 Aug 11.
• Larrabide I, Cruz Villa-Uriol M, Cardenes R, Pozo JM, Macho J, San Roman L, Blasco J, Vivas E, Marzo A, Hose DR, Frangi AF. Three-dimensional morphological analysis of intracranial aneurysms: a fully automated method for aneurysm sac isolation and quantification. Med Phys. 2011 May;38(5):2439-49. doi: 10.1118/1.3575417.
• Larrabide I, Geers AJ, Morales HG, Aguilar ML, Rufenacht DA. Effect of aneurysm and ICA morphology on hemodynamics before and after flow diverter treatment. J Neurointerv Surg. 2015 Apr;7(4):272-80. doi: 10.1136/neurintsurg-2014-011171. Epub 2014 Apr 1.
• Balocco S, Basset O, Courbebaisse G, Boni E, Frangi AF, Tortoli P, Cachard C. Estimation of the viscoelastic properties of vessel walls using a computational model and Doppler ultrasound. Phys Med Biol. 2010 Jun 21;55(12):3557-75. doi: 10.1088/0031-9155/55/12/019. Epub 2010 May 28.
• Ngoepe MN, Ventikos Y. Computational modelling of clot development in patient-specific cerebral aneurysm cases. J Thromb Haemost. 2016 Feb;14(2):262-72. doi: 10.1111/jth.13220. Epub 2016 Feb 5.
• Bernardini A, Larrabide I, Petrini L, Pennati G, Flore E, Kim M, Frangi AF. Deployment of self-expandable stents in aneurysmatic cerebral vessels: comparison of different computational approaches for interventional planning. Comput Methods Biomech Biomed Engin. 2012;15(3):303-11. doi: 10.1080/10255842.2010.527838. Epub 2011 Jun 1.
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• Stienen MN, Germans M, Burkhardt JK, Neidert MC, Fung C, Bervini D, Zumofen D, Rothlisberger M, Marbacher S, Maduri R, Robert T, Seule MA, Bijlenga P, Schaller K, Fandino J, Smoll NR, Maldaner N, Finkenstadt S, Esposito G, Schatlo B, Keller E, Bozinov O, Regli L; Swiss SOS Study Group. Predictors of In-Hospital Death After Aneurysmal Subarachnoid Hemorrhage: Analysis of a Nationwide Database (Swiss SOS [Swiss Study on Aneurysmal Subarachnoid Hemorrhage]). Stroke. 2018 Feb;49(2):333-340. doi: 10.1161/STROKEAHA.117.019328. Epub 2018 Jan 15.
• Maduri R, Starnoni D, Rocca A, Bervini D, Zumofen DW, Stienen MN, Schatlo B, Fung C, Robert T, Seule MA, Burkhardt JK, Maldaner N, Rothlisberger M, Blackham KA, Marbacher S, D'Alonzo D, Remonda L, Machi P, Gralla J, Bijlenga P, Saliou G, Ballabeni P, Levivier M, Messerer M, Daniel RT; Swiss SOS Group. Ruptured posterior circulation aneurysms: epidemiology, patterns of care, and outcomes from the Swiss SOS national registry. Acta Neurochir (Wien). 2019 Apr;161(4):769-779. doi: 10.1007/s00701-019-03812-9. Epub 2019 Jan 25.
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Helpful Links

• SwissNeuroFoundation website
• A benchmark for multi-class CoW segmentation, which serves as a first major step for the automatic CoW quantification. The top-performing models have been released on Zenodo.
• Manuscript describing the link https://zenodo.org/records/15665435
• A centerline and feature extraction pipeline that takes as input the CoW multi-class mask as produced by the TopCoW models and outputs a centerline graph as well as a complete CoW variant and feature description.
• Manuscript describing the link https://zenodo.org/records/17358162

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Estimated): March 1, 2040
• Study Completion (Estimated): March 1, 2040

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CCER 2022-00426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified information will be made available upon justifed request and approval by the board of ADB and ethics commissions of institutions that provided data
• IPD Sharing Time Frame: The data will be made available to the requesting party within 3 months and for a duration of 5 years with possible extension upon request. IPD data made available to the data user shell be destroyed at the end of the data sharing agreement.
• IPD Sharing Access Criteria: Any research on intracranial aneurysms
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR