NCT05526352

Brief 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). 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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
168mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
11 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jun 2015Mar 2040

Study Start

First participant enrolled

June 1, 2015

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
17.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2040

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

24.8 years

First QC Date

August 31, 2022

Last Update Submit

January 14, 2026

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Disease model validation

    Validation and improvement of the holistic disease model

    5 years

Secondary Outcomes (15)

  • Life expectancy

    20 years

  • Disability

    20 years

  • Cure

    20 years

  • Adverse events

    20 years

  • Aneurysm growth

    20 years

  • +10 more secondary outcomes

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

University of California

San Francisco, California, United States

RECRUITING

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

RECRUITING

University of Virginia

Virginia Beach, Virginia, United States

RECRUITING

Montreal Neurological Institute and Hospital, McGill University

Montreal, Canada

RECRUITING

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

ICAN

Nantes, France

RECRUITING

Department of Neurosurgery, Klinikum rechts der Isar, Technical University Munich

Munich, Germany

RECRUITING

University of Pecs

Pécs, Hungary

COMPLETED

Erasmus Medical Center

Rotterdam, Netherlands

COMPLETED

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Jagiellonian University Medical College

Krakow, Poland

RECRUITING

Barcelona Hospital General de Cataluna

Barcelona, Spain

COMPLETED

Hospital Clinic Barcelona

Barcelona, Spain

COMPLETED

IMIM - Hospital del Mar

Barcelona, Spain

RECRUITING

Neurochirurgie / Hôpitaux Universitaire de Genève

Geneva, 1211, Switzerland

RECRUITING

University Hospital of Lausanne (CHUV), CoLaus Datacenter

Lausanne, 1011, Switzerland

RECRUITING

Department of Neurosurgery, Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

RECRUITING

Klinik Hirslanded

Zurich, 8008, Switzerland

NOT YET RECRUITING

University College London

London, United Kingdom

RECRUITING

Radcliffe Infirmary

Oxford, United Kingdom

COMPLETED

Royal Hallamshire Hospital

Sheffield, United Kingdom

COMPLETED

Related Publications (124)

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  • 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.

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    PMID: 23899912RESULT

  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

    PMID: 22884968RESULT

  • 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.

    PMID: 21776779RESULT

  • 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.

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  • 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.

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  • Zumofen DW, Roethlisberger M, Achermann R, Bawarjan S, Stienen MN, Fung C, D'Alonzo D, Maldaner N, Ferrari A, Corniola MV, Schoeni D, Goldberg J, Valsecchi D, Robert T, Maduri R, Seule M, Burkhardt JK, Marbacher S, Bijlenga P, Blackham KA, Bucher HC, Mariani L, Guzman R; Swiss SOS Study Group. Factors associated with clinical and radiological status on admission in patients with aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2018 Oct;41(4):1059-1069. doi: 10.1007/s10143-018-0952-2. Epub 2018 Feb 10.

    PMID: 29428981RESULT

  • Stienen MN, Smoll NR, Fung C, Goldberg J, Bervini D, Maduri R, Chiappini A, Robert T, May A, Bijlenga P, Zumofen D, Roethlisberger M, Seule MA, Marbacher S, Fandino J, Schatlo B, Schaller K, Keller E, Bozinov O, Regli L; Swiss SOS Study Group. Home-Time as a Surrogate Marker for Functional Outcome After Aneurysmal Subarachnoid Hemorrhage. Stroke. 2018 Dec;49(12):3081-3084. doi: 10.1161/STROKEAHA.118.022808.

    PMID: 30735342RESULT

  • 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.

    PMID: 30680461RESULT

  • Stienen MN, Fung C, Bijlenga P, Zumofen DW, Maduri R, Robert T, Seule MA, Marbacher S, Geisseler O, Brugger P, Gutbrod K, Chicherio C, Monsch AU, Beaud V, Rossi S, Fruh S, Schmid N, Smoll NR, Keller E, Regli L; MoCA-DCI study group. Measuring the Impact of Delayed Cerebral Ischemia on Neuropsychological Outcome After Aneurysmal Subarachnoid Hemorrhage-Protocol of a Swiss Nationwide Observational Study (MoCA-DCI Study). Neurosurgery. 2019 May 1;84(5):1124-1132. doi: 10.1093/neuros/nyy155.

    PMID: 29762759RESULT

  • Roethlisberger M, Achermann R, Bawarjan S, Stienen MN, Fung C, D'Alonzo D, Maldaner N, Ferrari A, Corniola MV, Schoni D, Goldberg J, Valsecchi D, Robert T, Maduri R, Seule MA, Burkhardt JK, Marbacher S, Bijlenga P, Blackham KA, Bucher HC, Mariani L, Guzman R, Zumofen DW; Swiss SOS group. Impact of Aneurysm Multiplicity on Treatment and Outcome After Aneurysmal Subarachnoid Hemorrhage. Neurosurgery. 2019 Jun 1;84(6):E334-E344. doi: 10.1093/neuros/nyy331.

    PMID: 30113674RESULT

  • Starnoni D, Maduri R, Al Taha K, 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; Swiss SOS Group; Daniel RT. Ruptured PICA aneurysms: presentation and treatment outcomes compared to other posterior circulation aneurysms. A Swiss SOS study. Acta Neurochir (Wien). 2019 Jul;161(7):1325-1334. doi: 10.1007/s00701-019-03894-5. Epub 2019 Apr 26.

    PMID: 31025178RESULT

  • Haemmerli J, Lenga P, Hong B, Kursumovic A, Maldaner N, Burkhardt JK, Bijlenga P, Rufenacht DA, Schmidt NO, Vajkoczy P, Dengler J. Clinical implications and radiographic characteristics of the relation between giant intracranial aneurysms of the posterior circulation and the brainstem. Acta Neurochir (Wien). 2019 Sep;161(9):1747-1753. doi: 10.1007/s00701-019-04016-x. Epub 2019 Jul 29.

    PMID: 31359190RESULT

  • Maldaner N, Steinsiepe VK, Goldberg J, Fung C, Bervini D, May A, Bijlenga P, Schaller K, Roethlisberger M, Zumofen DW, D'Alonzo D, Marbacher S, Fandino J, Maduri R, Daniel RT, Burkhardt JK, Chiappini A, Robert T, Schatlo B, Seule MA, Weyerbrock A, Regli L, Stienen MN; Swiss SOS Study Group. Patterns of care for ruptured aneurysms of the middle cerebral artery: analysis of a Swiss national database (Swiss SOS). J Neurosurg. 2019 Nov 15;133(6):1811-1820. doi: 10.3171/2019.9.JNS192055. Print 2020 Dec 1.

    PMID: 31731273RESULT

  • Maldaner N, Zeitlberger AM, Sosnova M, Goldberg J, Fung C, Bervini D, May A, Bijlenga P, Schaller K, Roethlisberger M, Rychen J, Zumofen DW, D'Alonzo D, Marbacher S, Fandino J, Daniel RT, Burkhardt JK, Chiappini A, Robert T, Schatlo B, Schmid J, Maduri R, Staartjes VE, Seule MA, Weyerbrock A, Serra C, Stienen MN, Bozinov O, Regli L. Development of a Complication- and Treatment-Aware Prediction Model for Favorable Functional Outcome in Aneurysmal Subarachnoid Hemorrhage Based on Machine Learning. Neurosurgery. 2021 Jan 13;88(2):E150-E157. doi: 10.1093/neuros/nyaa401.

    PMID: 33017031RESULT

  • Wessels L, Fekonja LS, Achberger J, Dengler J, Czabanka M, Hecht N, Schneider U, Tkatschenko D, Schebesch KM, Schmidt NO, Mielke D, Hosch H, Ganslandt O, Grawe A, Hong B, Walter J, Guresir E, Bijlenga P, Haemmerli J, Maldaner N, Marbacher S, Nurminen V, Zitek H, Dammers R, Kato N, Linfante I, Pedro MT, Wrede K, Wang WT, Wostrack M, Vajkoczy P. Diagnostic reliability of the Berlin classification for complex MCA aneurysms-usability in a series of only giant aneurysms. Acta Neurochir (Wien). 2020 Nov;162(11):2753-2758. doi: 10.1007/s00701-020-04565-6. Epub 2020 Sep 15.

    PMID: 32929543RESULT

  • Schatlo B, Fung C, Stienen MN, Fathi AR, Fandino J, Smoll NR, Zumofen D, Daniel RT, Burkhardt JK, Bervini D, Marbacher S, Reinert M, D Alonzo D, Ahlborn P, Mendes Pereira V, Roethlisberger M, Seule M, Kerkeni H, Remonda L, Weyerbrock A, Woernle K, Venier A, Perren F, Sailer M, Robert T, Rohde V, Schoni D, Goldberg J, Nevzati E, Diepers M, Gralla J, Z'Graggen W, Starnoni D, Woernle C, Maldaner N, Kulcsar Z, Mostaguir K, Maduri R, Eisenring C, Bernays R, Ferrari A, Dan-Ura H, Finkenstadt S, Gasche Y, Sarrafzadeh A, Jakob SM, Corniola M, Baumann F, Regli L, Levivier M, Hildebrandt G, Landolt H, Mariani L, Guzman R, Beck J, Raabe A, Keller E, Bijlenga P, Schaller K. Incidence and Outcome of Aneurysmal Subarachnoid Hemorrhage: The Swiss Study on Subarachnoid Hemorrhage (Swiss SOS). Stroke. 2021 Jan;52(1):344-347. doi: 10.1161/STROKEAHA.120.029538. Epub 2020 Dec 4.

    PMID: 33272133RESULT

  • Bernava G, Sandralegar A, Hofmeister J, Rosi A, Yilmaz H, Morel S, Reymond P, Brina O, Muster M, Lovblad KO, Schaller K, Bijlenga P, Machi P. Endovascular treatment of unruptured intracranial aneurysms at a single center: Outcomes, selection strategy, and transparent communication for patient decision-making. Interv Neuroradiol. 2025 Nov 7:15910199251394476. doi: 10.1177/15910199251394476. Online ahead of print.

    PMID: 41204111RESULT

  • Delucchi M, Bijlenga P, Morel S, Furrer R, Hostettler IC, Bakker MK, Bourcier R, Lindgren A, Maschke S, Bozinov O, Houlden H, Werring D, Ruigrok YM, Wostrack M, Meyer B, Neidert MC; International Stroke Genetics Consortium (ISGC) Intracranial Aneurysm Working Group; Genetics and Observational Subarachnoid Haemorrhage (GOSH) Study Investigators; Hirsch S, Spinner GR. Mixed-effects additive Bayesian networks for the assessment of ruptured intracranial aneurysms: Insights from multicenter data. Comput Biol Med. 2026 Jan 15;201:111380. doi: 10.1016/j.compbiomed.2025.111380. Epub 2025 Dec 23.

    PMID: 41443054RESULT

  • Freneau M, Blanchet R, Bodet M, Benichi S, Mrad MA, Batta SPR, Rio M, Bonnaud S, Lindenbaum P, Laporte F, Cuenot S, Quillard T, Maillasson M, Morel S, Kwak BR, Bijlenga P, Deleuze JF, Dina C, Chatel S, Bourcereau E, Jouan S, Consoli A, Dargazanli C, Ognard J, Desal H, Vion AC, Bourcier R, Loirand G, Redon R. Identification of rare missense variants reducing cathepsin O secretion in families with intracranial aneurysm. Cardiovasc Res. 2026 Feb 24;122(1):98-111. doi: 10.1093/cvr/cvaf279.

    PMID: 41508845RESULT

  • Cayron AF, Morel S, Azam M, Haemmerli J, Aoki T, Bijlenga P, Allemann E, Kwak BR. Enhanced intracranial aneurysm development in a rat model of polycystic kidney disease. Cardiovasc Res. 2025 Jun 12;121(6):915-928. doi: 10.1093/cvr/cvaf063.

    PMID: 40249101RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples CSF Aneurysm domes Saliva Stool

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Philippe Bijlenga, PD MD PhD

    Geneva University

    PRINCIPAL INVESTIGATOR

  • Sandrine Morel, PD PhD

    Hôpitaux Universitaire de Genève

    STUDY CHAIR

Central Study Contacts

Sven Hirsch, Dr

CONTACT

+41 58 934 54 44hirc@zhaw.ch

Philippe Bijlenga, PD MD PhD

CONTACT

+41 22 372 34 26philippe.bijlenga@hcuge.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

June 1, 2015

Primary Completion (Estimated)

March 1, 2040

Study Completion (Estimated)

March 1, 2040

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Deidentified information will be made available upon justifed request and approval by the board of ADB and ethics commissions of institutions that provided data

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
Access Criteria
Any research on intracranial aneurysms

Locations

HU(1)CH(4)DE(1)FR(1)CA(1)PL(1)GB(3)US(3)NL(2)FI(2)ES(3)