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Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms

ConditionsAneurysmBrain AneurysmCongenital Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

The purpose of the bCAN study is to create a prospective collection of multimodal data and human samples, linked to the French Intracranial Aneurysm Registry (FRAN).

The aim of bCAN is to enable risk stratification of ruptured ICAs by redefining "intracranial aneurysm disease". The description of genotypically and phenotypically specific subgroups of cases will pave the way for improved patient management based on new diagnostic/prognostic strategies among AIC carriers, either in a familial context, or at the level of the general population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any adult patient consulting for a definite and typical bifurcation AIC authenticated on MRI and/or cerebral arteriography

Aneurysm discovered less than a year ago, with initial imaging (MRI and/or CTA and DSA) available

Written consent obtained for study participation

Patient covered by a social security plan

Disqualifiers

Syndromic diagnosis known to cause ICA: Marfan syndrome, OSA with SMAD 3, Elhers Danlos syndrome type II and IV, Autosomal Dominant Cystic Fibrosis, Moya-Moya syndrome

AIC with : Dissecting or fusiform, Associated with arteriovenous malformation, Blister-like, Mycotic

Cerebral white matter pathology detected on MRI evoking : Col4a1 mutation

Patient under guardianship or conservatorship

Trial design

Design model

Single group

Treatments tested in this trial

  • blood or saliva sample

    Other intervention

    Collection of blood or saliva

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: ICA casesOther 1 intervention

Trial outcomes

Primary outcomes

1

Performance of a predictive model allowing the classification of ICA subphenotypes

The performance of a predictive model allowing the classification of ICA subphenotypes will be analysed through the study of genetic results, quantitative features extracted from imaging and clinical data on rupture

Time frame
36 months

Secondary outcomes

1

Characterization of arterial bifurcations

Quantitative morphological measurements of arterial bifurcations assessed using image processing tools enabling automatic characterization (artery diameters (in mm); artery cross-sections (in mm²); angles separating arteries (in degrees)

Time frame
36 months
2

Characterization of aneurysmal sacs

Quantitative morphological measurements of aneurysmal sacs assessed using image processing tools enabling automatic characterization (volume (in mm³); external surface area of the envelope (mm²); neck area (mm²))

Time frame
36 months
3

Screening of genetic mutations

Presence of genetic mutations in patients with intracranial aneurysms compared with a reference population, but also in a familial context. Genetic variations will be studied by whole exome sequencing

Time frame
36 months
4

Correlation between genotypes and phenotypes

Correlations between genetic mutations and the different clinical and biological phenotypes described in patients with sporadic ICA

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Federation of Medical Specialties

Collaborator

Source ClinicalTrials.gov
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