Multimodal Biocollection Linked to the French Register of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 35
- 主要终点
- Performance of a predictive model allowing the classification of ICA subphenotypes
研究概览
简要总结
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.
详细描述
The main objective of bCAN study is to build a predictive model of intracranial aneurysm phenotypes through the combination of information on genetic mutations, imaging findings and ICA rupture characteristics.
The secondary objectives of the bCAN study are (i) to study morphological characterization of ICA and vascular bifurcations, (ii) to deepen knowledge of genotype/clinical and biological phenotype relationships according to the genes identified in the different families, (iii) to research and validate the relationships between genotypes and phenotypes (including rupture) of ICA in a large population of sporadic ICA cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for sporadic ICA cases:
- •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
- •Inclusion criteria for index and related cases (familial forms) of intracranial aneurysms (ICA):
- •Index case: Any adult patient consulting for a definite and typical bifurcation ICA presenting at least one other case with ICA related (child, parent, brother, sister) detected by MRI with at least one Time of Flight (TOF) sequence.
- •Family relatives: children, parents, brothers, sisters, of legal age, of patients with a family history of definite, typical bifurcation AIC (≥ 4 affected), Screening to be performed using MRI with at least a Time of Flight (TOF) sequence.
- •Written consent to participate in the study
- •Patient and relatives covered by a social security plan
排除标准
- •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
- •Person under court protection
- •Contraindication to an MRI scan
研究组 & 干预措施
ICA cases
Any adult patient consulting for a definite and typical bifurcation AIC authenticated on MRI and/or cerebral arteriography
干预措施: blood or saliva sample (Other)
结局指标
主要结局
Performance of a predictive model allowing the classification of ICA subphenotypes
时间窗: 36 months
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
次要结局
- Characterization of arterial bifurcations(36 months)
- Characterization of aneurysmal sacs(36 months)
- Screening of genetic mutations(36 months)
- Correlation between genotypes and phenotypes(36 months)