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| Name | Class |
|---|---|
| Centre Hospitalier St Anne | OTHER |
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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unruptured intracranial aneurysms | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life related to the growth of UIA. | 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. |
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Inclusion Criteria :
Exclusion Criteria :
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain BOURCIER, MD | Contact | 33240165608 | romain.bourcier@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Romain BOURCIER, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clairval's Hospital | Recruiting | Marseille | Bouches-du-Rhône | 13000 | France | |
| Brest University Hospital |
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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. | 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. | Incidence of growth, stratified by clinical, genetics or biological features. | 5 years |
| Incidence of IA rupture | Incidence of IA rupture, stratified by clinical, genetics or biological features. | 5 years |
| quality of life patients related to the growth of UIA. | Completion of standardized EQ5D questionnaire to measure quality of life patients | 5 years |
| Construction of an automatized tool of AWE pattern | 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 |
| Recruiting |
| Brest |
| Finistère |
| 29200 |
| France |
| Bordeaux University Hospital | Recruiting | Bordeaux | Gironde | 33000 | France |
| Toulouse University Hospital | Recruiting | Toulouse | Haute-Garonne | 31000 | France |
| Limoges University Hospital | Recruiting | Limoges | Haute-Vienne | 87000 | France |
| Rennes University Hospital | Recruiting | Rennes | Ille-et-Vilaine | 35000 | France |
| Tours University Hospital | Recruiting | Tours | Indre-et-Loire | 37000 | France |
| Nantes University Hospital | Recruiting | Nantes | Loire-Atlantique | 44000 | France |
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| Angers University Hospital | Recruiting | Angers | Maine et Loire | 49000 | France |
| Reims University Hospital | Not yet recruiting | Reims | Marne | 51100 | France |
| Nancy University Hospital | Recruiting | Nancy | Meurthe-et-Moselle | 54000 | France |
| AP-HP La Pitié-Salpêtrière Hospital | Recruiting | Paris | Paris | 75000 | France |
| AP-HP Le Kremlin Bicêtre Hospital | Recruiting | Paris | Paris | 75000 | France |
| Rostchild Foundation Hospital | Recruiting | Paris | Paris | 75000 | France |
| Rouen University Hospital | Recruiting | Rouen | Seine-Maritime | 76000 | France |
| Amiens University Hospital | Recruiting | Amiens | Somme | 80000 | France |
| Creteil University Hospital | Recruiting | Créteil | Val-de-Marne | 94000 | France |
| CHU de Besançon | Recruiting | Besançon | France |
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| CHU de Caen | Recruiting | Caen | France |
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| CHU de Clermont Ferrand | Recruiting | Clermont-Ferrand | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU de Poitiers | Recruiting | Poitiers | France |
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| CHU de saint Etienne | Recruiting | Saint-Etienne | France |
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| CHU de Strasbourg | Recruiting | Strasbourg | France |
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| Hôpital Foch | Recruiting | Suresnes | France |
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| St Anne HIA | Recruiting | Toulon | France |
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| Ste Anne's Hospital | Recruiting | Paris | Île-de-France Region | 75674 | France |
| UMC Utrecht | Completed | Utrecht | 3500 | Netherlands |
| InselHospital Bern | Not yet recruiting | Bern | 3000 | Switzerland |