未破裂的脑动脉瘤：进化的预测 (U-CAN)
The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.
研究概览
详细说明
Management of small (<7mm) unruptured intracranial aneurysms (UIA) remains controversial. Previous retrospective studies have suggested that post gadolinium arterial wall enhancement (AWE) of unruptured intracranial aneurysms on MR imaging may reflect aneurysm wall instability, and hence may highlight a higher risk of UIA growth over time. This multicentric prospective cohort aims at exploring vessel wall imaging findings of UIAs with consecutive follow-up to substantiate these assumptions.The objective is to develop diagnostic and predictive tools for the risk of IA evolution. The aim is to demonstrate in clinical practice the predictive value of (AWE) for UIA growth. The growth will be determined by any modification of the UIA measurement. Both UIA growth and the UIA wall enhancement will be assessed in consensus by two expert neuroradiologists.The French prospective UCAN project is a non-interventional international wide and multicentric prospective cohort. UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Romain BOURCIER, MD
- 电话号码：33240165608
- 邮箱：romain.bourcier@chu-nantes.fr
学习地点
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Besançon、法国
- 招聘中
- CHU de Besançon
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首席研究员：
- Alessandra BIONDI
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接触：
- Alessandra BIONDI
- 电话号码：+33 3 81 66 81 66
- 邮箱：biondi.alessandra@gmail.com
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Caen、法国
- 招聘中
- CHU de Caen
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接触：
- Charlotte BARBIER
- 电话号码：+33 2 31 06 31 06
- 邮箱：barbier-ch@chu-caen.fr
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首席研究员：
- Charlotte BARBIER
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Clermont-Ferrand、法国
- 招聘中
- CHU de Clermont Ferrand
-
接触：
- Emmanuel CHABERT
- 电话号码：+33 4 73 751 747
- 邮箱：echabert@chu-clermontferrand.fr
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首席研究员：
- Emmanuel CHABERT
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Colmar、法国
- 尚未招聘
- Hôpitaux Civils de Colmar
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接触：
- Pablo Ariel LEBEDINSKY, MD
- 电话号码：+33 3.89.12.44.39
- 邮箱：pablo.lebedinsky@ch-colmar.fr
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首席研究员：
- Pablo Ariel LEBEDINSKY
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Dijon、法国
- 招聘中
- CHU Dijon
-
接触：
- Pierre THOUANT
- 电话号码：+33 3 80 29 30 31
- 邮箱：pierrethouant@gmail.com
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首席研究员：
- Pierre THOUANT
-
Poitiers、法国
- 招聘中
- CHU de Poitiers
-
首席研究员：
- Samy BOUCEBCI
-
接触：
- Samy BOUCEBCI
- 电话号码：+33 5 49 44 44 44
- 邮箱：Samy.BOUCEBCI@chu-poitiers.fr
-
Saint-Etienne、法国
- 招聘中
- CHU de saint Etienne
-
首席研究员：
- Marina SACHET
-
接触：
- Marina SACHET
- 电话号码：+33 4 77 82 80 00
- 邮箱：Marina.Sachet@chu-st-etienne.fr
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Strasbourg、法国
- 招聘中
- CHU de Strasbourg
-
首席研究员：
- Raoul POP
-
接触：
- Raoul POP
- 电话号码：+33 3 88 11 67 68
- 邮箱：raoul.pop@chru-strasbourg.fr
-
Suresnes、法国
- 招聘中
- Hôpital Foch
-
首席研究员：
- Arturo CONSOLI
-
接触：
- Arturo CONSOLI
- 电话号码：+33 1 46 25 20 00
- 邮箱：a.consoli@hopital-foch.com
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Toulon、法国
- 招聘中
- St Anne HIA
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接触：
- Quentin Holay
- 邮箱：qholay@gmail.com
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Bouches-du-Rhône
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Marseille、Bouches-du-Rhône、法国、13000
- 招聘中
- Clairval's Hospital
-
-
Finistère
-
Brest、Finistère、法国、29200
- 招聘中
- Brest University Hospital
-
-
Gironde
-
Bordeaux、Gironde、法国、33000
- 招聘中
- Bordeaux University Hospital
-
-
Haute-Garonne
-
Toulouse、Haute-Garonne、法国、31000
- 招聘中
- Toulouse University Hospital
-
-
Haute-Vienne
-
Limoges、Haute-Vienne、法国、87000
- 招聘中
- Limoges University Hospital
-
-
Ille-et-Vilaine
-
Rennes、Ille-et-Vilaine、法国、35000
- 招聘中
- Rennes University Hospital
-
-
Indre-et-Loire
-
Tours、Indre-et-Loire、法国、37000
- 招聘中
- Tours University Hospital
-
-
Loire-Atlantique
-
Nantes、Loire-Atlantique、法国、44000
- 招聘中
- Nantes University Hospital
-
首席研究员：
- Romain BOURCIER, MD
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-
Maine et Loire
-
Angers、Maine et Loire、法国、49000
- 招聘中
- Angers University Hospital
-
-
Marne
-
Reims、Marne、法国、51100
- 撤销
- Reims University Hospital
-
-
Meurthe-et-Moselle
-
Nancy、Meurthe-et-Moselle、法国、54000
- 招聘中
- Nancy University Hospital
-
-
Paris
-
Paris、Paris、法国、75000
- 招聘中
- AP-HP La Pitié-Salpêtrière Hospital
-
Paris、Paris、法国、75000
- 招聘中
- AP-HP Le Kremlin Bicêtre Hospital
-
Paris、Paris、法国、75000
- 招聘中
- Rostchild Foundation Hospital
-
-
Seine-Maritime
-
Rouen、Seine-Maritime、法国、76000
- 招聘中
- Rouen University Hospital
-
-
Somme
-
Amiens、Somme、法国、80000
- 招聘中
- Amiens University Hospital
-
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Île-de-France Region
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Paris、Île-de-France Region、法国、75674
- 招聘中
- Ste Anne's Hospital
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-
-
-
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Bern、瑞士、3000
- 尚未招聘
- InselHospital Bern
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-
-
-
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Utrecht、荷兰、3500
- 完全的
- UMC Utrecht
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The recruited population is composed of subjects carrying unruptured asymptomatic typical IA of bifurcation for whom a clinical, a biological and an imaging follow-up, without occlusion treatment, was scheduled by local multidisciplinary staff.
描述
Inclusion Criteria :
- Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter.
- Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering.
- Age > 18 years old.
Exclusion Criteria :
- A failure to obtain informed consent
- Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia)
- Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding)
- A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation
- A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease
- Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The aim is to evaluate in clinical practice the predictive value of UIA wall enhancement for UIA growth. It will allow to set up a secure, efficient and personalized follow-up.
大体时间：5 years
|
In order to evaluate the informative value of AWE for UIA growth, investigators will consider as primary endpoint the growth of the UIA after the complete follow-up at 3 years. |
5 years
|
|
Predictive value of UIA wall enhancement for UIA growth
大体时间：at 1 year
|
This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert. |
at 1 year
|
|
Predictive value of UIA wall enhancement for UIA growth
大体时间：at 3 years
|
This event could occur at any time during the follow-up if an UIA becomes symptomatic but will be systematically assessed by MRI. UIA growth will be assessed blindly and independently by two expert neuroradiologists, routinely involved in UIA management and disagreement will be solved by consensus with involvement of a third expert. UIA wall enhancement status will be defined independently by two different expert neuroradiologists, with > 5yrs experience in intracranial vessel wall imaging. Disagreement will be solved by consensus with involvement of a third expert. |
at 3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life related to the growth of UIA.
大体时间：5 years
|
Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up. |
5 years
|
|
AWE variation patterns related to the growth of UIA.
大体时间：5 years
|
Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients |
5 years
|
|
Clinical, genetics or biological factors related to the growth of UIA.
大体时间：5 years
|
Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase…) features recorded. |
5 years
|
|
Incidence of growth of UIA.
大体时间：5 years
|
Incidence of growth, stratified by clinical, genetics or biological features. |
5 years
|
|
Incidence of IA rupture
大体时间：5 years
|
Incidence of IA rupture, stratified by clinical, genetics or biological features. |
5 years
|
|
quality of life patients related to the growth of UIA.
大体时间：5 years
|
Completion of standardized EQ5D questionnaire to measure quality of life patients |
5 years
|
|
Construction of an automatized tool of AWE pattern
大体时间：5 years
|
Construction and evaluation of an automatized tool of AWE patterns, as compared to the visual analysis of experts, in the form of a decision-making tool. |
5 years
|
合作者和调查者
调查人员
- 首席研究员：Romain BOURCIER, MD、Nantes University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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