Intracranial Aneurysm@neurISTNCT05526352
@neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms
An observational study of Intracranial Aneurysm, run by University Hospital, Geneva at 22 sites in 11 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 20,000 participants
- Where
- 22 sitesin 11 countries
- Study dates
- 1 Jun 2015to 1 Mar 2040
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prospective consecutive recruitment of cases newly diagnosed intracranial aneurysm in each participating clinical center.
Who may be able to join
- 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
Who cannot join
- failure of a candidate to contribute clinical data,
- refusal to provide informed consent.
Trial locations and contacts
22 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 11 countries
Switzerland4 sites, 4 recruiting
- Recruiting
Neurochirurgie / Hôpitaux Universitaire de Genève
Geneva, 1211
Philippe Bijlenga, PD MD PhD, +41795533772, philippe.bijlenga@hcuge.ch
Karl Schaller, Prof, +41223728201, karl.schaller@hcuge.ch
- Recruiting
University Hospital of Lausanne (CHUV), CoLaus Datacenter
Lausanne, 1011
Peter Vollenweider, Prof
- Recruiting
Department of Neurosurgery, Cantonal Hospital St. Gallen
Sankt Gallen
Isabel Hostettler
- Not yet recruiting
Klinik Hirslanded
Zurich, 8008
Daniel Rüfenacht, Prof, +41 44 387 28 50, daniel.rufenacht@hirslanden.ch
Isabel Wanke, Prof, +41 44 387 28 50, isabel.wanke@hirslanden.ch
United States3 sites, 3 recruiting
- Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio
Joseph Broderick
Daniel Woo
- Recruiting
University of California
San Francisco, California
Nerissa Ko
- Recruiting
University of Virginia
Virginia Beach, Virginia
Bradford Worrall
Spain3 sites, 1 recruiting
- Completed
Barcelona Hospital General de Cataluna
Barcelona
- Completed
Hospital Clinic Barcelona
Barcelona
- Recruiting
IMIM - Hospital del Mar
Barcelona
Jordi Jimenez Corde
United Kingdom3 sites, 1 recruiting
- Recruiting
University College London
London
David Werring
- Completed
Radcliffe Infirmary
Oxford
- Completed
Royal Hallamshire Hospital
Sheffield
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Behman Rezai Jahromi
- Recruiting
Kuopio University Hospital
Kuopio
Antti Lindgren
Netherlands2 sites, 1 recruiting
- Completed
Erasmus Medical Center
Rotterdam
- Recruiting
University Medical Center Utrecht
Utrecht
Ynte Ruigrok
Canada1 site, 1 recruiting
- Recruiting
Montreal Neurological Institute and Hospital, McGill University
Montreal
Guy Rouleau
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich
Munich
Maria Wostrack
Isabel Hostettler
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College
Krakow
Joanna Pera
About this study
Official title: @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.
Read more
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.
Read the 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
- Conditions
- Intracranial Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Disease model validation
Validation and improvement of the holistic disease model
Measured: 5 years
Secondary outcomes (15)
Life expectancy
Age at death
Measured: 20 years
Disability
Disease induced disability on modified Rankin scale and duration of disability
Measured: 20 years
Cure
Absence of new treatments or bleeding after initial treatment
Measured: 20 years
Adverse events
Aneurysm rupture after diagnosis or treatment related severe complications
Measured: 20 years
Aneurysm growth
Observation of the growth of an aneurysm after diagnosis
Measured: 20 years
Radiological aneurysm exclusion
Ability to completely and permanently exclude the lesion with the treatment
Measured: 20 years
Recurrence
Recurrence or repermeabilisation of the aneurysm after treatment
Measured: 20 years
Neo-aneurysm formation
New identification of aneurysm during follow up previously not diagnosed
Measured: 20 years
Quality of life
regular measurement of quality of life during follow-up (i.e. EQ-5D)
Measured: 20 years
Neuropsychological performance
regular measurement of neuropsychological performance (i.e. MMSE, MOCA, dedicated evaluation)
Measured: 20 years
Neurological status
regular measurement of the NIHSS during follow-up
Measured: 20 years
Cranial nerves status
regular evaluation of cranial nerve function during follow-up
Measured: 20 years
Occurence of hydrocephalus
need for internal CSF drainage system implantation
Measured: 20 years
Occurence of vasospasm
need for aggressive hypertensive treatment or endo-vascular rescue therapy (IA vasodilator injection, balloon angioplasty)
Measured: 20 years
Delayed Cerebral Injury (DCI)
Radiological secondary brain injury associated to vasospasm excluding injuries associated with aneurysm intervention
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jun 2015
- Primary completion1 Mar 2040 (estimated)
- Study completion1 Mar 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (125)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, Klinik Hirslanden, Zurich
- Responsible party
- Principal investigator, Philippe Bijlenga, University Hospital, Geneva
- Investigators
- Philippe Bijlenga, PD MD PhD, Principal investigator, Geneva UniversitySandrine Morel, PD PhD, Study chair, Hôpitaux Universitaire de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526352
- Sponsor's protocol ID
- CCER 2022-00426
- Acronym
- @neurIST
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Deidentified information will be made available upon justifed request and approval by the board of ADB and ethics commissions of institutions that provided data
Publications
Benkner S, Arbona A, Berti G, Chiarini A, Dunlop R, Engelbrecht G, Frangi AF, Friedrich CM, Hanser S, Hasselmeyer P, Hose RD, Iavindrasana J, Kohler M, Iacono LL, Lonsdale G, Meyer R, Moore B, Rajasekaran H, Summers PE, Wohrer A, Wood S. @neurIST: infrastructure for advanced disease management through integration of heterogeneous data, computing, and complex processing services. IEEE Trans Inf Technol Biomed. 2010 Nov;14(6):1365-77. doi: 10.1109/TITB.2010.2049268. Epub 2010 Apr 29.
PubMed 20435543Bijlenga P, Morel S, Hirsch S, Schaller K, Rufenacht D. Plea for an international Aneurysm Data Bank: description and perspectives. Neurosurg Focus. 2019 Jul 1;47(1):E17. doi: 10.3171/2019.4.FOCUS19185.
PubMed 31261121Schatlo B, Fung C, Fathi AR, Sailer M, Winkler K, Daniel RT, Bijlenga P, Ahlborn P, Seule M, Zumofen D, Reinert M, Woernle C, Stienen M, Levivier M, Hildebrandt G, Mariani L, Bernays R, Fandino J, Raabe A, Keller E, Schaller K. Introducing a nationwide registry: the Swiss study on aneurysmal subarachnoid haemorrhage (Swiss SOS). Acta Neurochir (Wien). 2012 Dec;154(12):2173-8; discussion 2178. doi: 10.1007/s00701-012-1500-4. Epub 2012 Oct 6.
PubMed 23053275Iavindrasana J, Lo Iacono L, Muller H, Periz I, Summers P, Wright J, Friedrich CM, Dach H, Gattermayer T, Engelbrecht G, Benkner S, Hofmann-Apitius M, Dunlop R, Arbona A, Rajasekaran H, Fingberg J, Chiarini A, Moore B, Bijlenga P, Hose RD, Frangi AF. The @neurIST project. Stud Health Technol Inform. 2008;138:161-4. No abstract available.
PubMed 18560117Dunlop R, Arbona A, Rajasekaran H, Lo Iacono L, Fingberg J, Summers P, Benkner S, Engelbrecht G, Chiarini A, Friedrich CM, Moore B, Bijlenga P, Iavindrasana J, Hose RD, Frangi AF; @neurIST Consortium. @neurIST - chronic disease management through integration of heterogeneous data and computer-interpretable guideline services. Stud Health Technol Inform. 2008;138:173-7.
PubMed 18560119Boeker M, Stenzhorn H, Kumpf K, Bijlenga P, Schulz S, Hanser S. The @neurIST ontology of intracranial aneurysms: providing terminological services for an integrated IT infrastructure. AMIA Annu Symp Proc. 2007 Oct 11;2007:56-60.
PubMed 18693797Cayron AF, Bejuy O, Vargas MI, Colin DJ, Aoki T, Lovblad KO, Bijlenga P, Kwak BR, Allemann E, Morel S. Time-of-flight and black-blood MRI to study intracranial arteries in rats. Eur Radiol Exp. 2024 Jan 9;8(1):3. doi: 10.1186/s41747-023-00407-z.
PubMed 38191711Reymond 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.
PubMed 19429832Schaap 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.
PubMed 19632885Yasuno 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.
PubMed 20364137Morgan 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.
PubMed 18834494Reymond 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.
PubMed 21622820Bauer-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.
PubMed 19638971Morbiducci 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.
PubMed 26740210Augsburger 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.
PubMed 19705075
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- @neurIST : Informatique biomédicale intégrée Pour la Gestion Des anévrismes cérébraux
- ClinicalTrials.gov ID
- NCT05526352
- Acronym / sponsor ID
- @neurIST / CCER 2022-00426
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, Klinik Hirslanden, Zurich
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Mar 2040 (estimated)
- Study completion
- 1 Mar 2040 (estimated)
- First posted
- 2 Sep 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective consecutive recruitment of cases newly diagnosed intracranial aneurysm in each participating clinical center.
Key inclusion criteria (4 listed)
- 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.
- 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
Key exclusion criteria (2 listed)
- failure of a candidate to contribute clinical data,
- refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease model validation
Time frame: 5 years
Validation and improvement of the holistic disease model
15 secondary outcomes
Life expectancy
Time frame: 20 years
Disability
Time frame: 20 years
Cure
Time frame: 20 years
Adverse events
Time frame: 20 years
Aneurysm growth
Time frame: 20 years
Radiological aneurysm exclusion
Time frame: 20 years
Recurrence
Time frame: 20 years
Neo-aneurysm formation
Time frame: 20 years
Quality of life
Time frame: 20 years
Neuropsychological performance
Time frame: 20 years
Neurological status
Time frame: 20 years
Cranial nerves status
Time frame: 20 years
Occurence of hydrocephalus
Time frame: 20 years
Occurence of vasospasm
Time frame: 20 years
Delayed Cerebral Injury (DCI)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 20435543Benkner S, Arbona A, Berti G, Chiarini A, Dunlop R, Engelbrecht G, Frangi AF, Friedrich CM, Hanser S, Hasselmeyer P, Hose RD, Iavindrasana J, Kohler M, Iacono LL, Lonsdale G, Meyer R, Moore B, Rajasekaran H, Summers PE, Wohrer A, Wood S. @neurIST: infrastructure for advanced disease management through integration of heterogeneous data, computing, and complex processing services. IEEE Trans Inf Technol Biomed. 2010 Nov;14(6):1365-77. doi: 10.1109/TITB.2010.2049268. Epub 2010 Apr 29.
- Background: PubMed 31261121Bijlenga P, Morel S, Hirsch S, Schaller K, Rufenacht D. Plea for an international Aneurysm Data Bank: description and perspectives. Neurosurg Focus. 2019 Jul 1;47(1):E17. doi: 10.3171/2019.4.FOCUS19185.
- Background: PubMed 23053275Schatlo B, Fung C, Fathi AR, Sailer M, Winkler K, Daniel RT, Bijlenga P, Ahlborn P, Seule M, Zumofen D, Reinert M, Woernle C, Stienen M, Levivier M, Hildebrandt G, Mariani L, Bernays R, Fandino J, Raabe A, Keller E, Schaller K. Introducing a nationwide registry: the Swiss study on aneurysmal subarachnoid haemorrhage (Swiss SOS). Acta Neurochir (Wien). 2012 Dec;154(12):2173-8; discussion 2178. doi: 10.1007/s00701-012-1500-4. Epub 2012 Oct 6.
- Background: PubMed 18560117Iavindrasana J, Lo Iacono L, Muller H, Periz I, Summers P, Wright J, Friedrich CM, Dach H, Gattermayer T, Engelbrecht G, Benkner S, Hofmann-Apitius M, Dunlop R, Arbona A, Rajasekaran H, Fingberg J, Chiarini A, Moore B, Bijlenga P, Hose RD, Frangi AF. The @neurIST project. Stud Health Technol Inform. 2008;138:161-4. No abstract available.
- Background: PubMed 18560119Dunlop R, Arbona A, Rajasekaran H, Lo Iacono L, Fingberg J, Summers P, Benkner S, Engelbrecht G, Chiarini A, Friedrich CM, Moore B, Bijlenga P, Iavindrasana J, Hose RD, Frangi AF; @neurIST Consortium. @neurIST - chronic disease management through integration of heterogeneous data and computer-interpretable guideline services. Stud Health Technol Inform. 2008;138:173-7.
- Background: PubMed 18693797Boeker M, Stenzhorn H, Kumpf K, Bijlenga P, Schulz S, Hanser S. The @neurIST ontology of intracranial aneurysms: providing terminological services for an integrated IT infrastructure. AMIA Annu Symp Proc. 2007 Oct 11;2007:56-60.
- Background: PubMed 38191711Cayron AF, Bejuy O, Vargas MI, Colin DJ, Aoki T, Lovblad KO, Bijlenga P, Kwak BR, Allemann E, Morel S. Time-of-flight and black-blood MRI to study intracranial arteries in rats. Eur Radiol Exp. 2024 Jan 9;8(1):3. doi: 10.1186/s41747-023-00407-z.
- Results publication: PubMed 19429832Reymond 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.
- Results publication: PubMed 19632885Schaap 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.
- Results publication: PubMed 20364137Yasuno 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.
- Results publication: PubMed 18834494Morgan 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.
- Results publication: PubMed 21622820Reymond 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.
- SwissNeuroFoundation websiteLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Manuscript describing the link https://zenodo.org/records/15665435Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Manuscript describing the link https://zenodo.org/records/17358162Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified information will be made available upon justifed request and approval by the board of ADB and ethics commissions of institutions that provided data
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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.
Philippe Bijlenga, PD MD PhD principal investigator
Geneva University
Sandrine Morel, PD PhD study chair
Hôpitaux Universitaire de Genève
22 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by University Hospital, Geneva at 22 sites in 11 countries.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Switzerland, United States, Spain, United Kingdom, Finland and 6 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Hirsch, Dr (+41 58 934 54 44, hirc@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease model validation (time frame: 5 years). 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 NCT05526352, which also lists 125 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 16 Jan 2026.