Unruptured Cerebral Aneurysm: Prediction of Evolution

Recruiting

• Conditions: Unruptured Intracranial Aneurysm

• Registration Number: NCT04578808
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2019-08-19
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2029-03-15
• Study Completion: 2029-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of UIA wall enhancement for UIA growth	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.
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.	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.

Secondary Outcome Measures

Name	Time	Method
AWE variation patterns related to the growth of UIA.	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
Quality of life related to the growth of UIA.	5 years	Evaluation of the quality of life (QOL) of untreated patients with UIA during the follow-up.
Incidence of IA rupture	5 years	Incidence of IA rupture, stratified by clinical, genetics or biological features.
Clinical, genetics or biological factors related to the growth of UIA.	5 years	Clinical, genetic (blood serum level of circulating ANGPTL6) and biological (plasma factors as circulating ANGPTL6 levels, metalloproteinase...) features recorded.
Incidence of growth of UIA.	5 years	Incidence of growth, stratified by clinical, genetics or biological features.
quality of life patients related to the growth of UIA.	5 years	Completion of standardized EQ5D questionnaire to measure quality of life patients
Construction of an automatized tool of AWE pattern	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.

Trial Locations

Locations (20)

Limoges University Hospital; 🇫🇷 Limoges, Haute-Vienne, France

Nancy University Hospital; 🇫🇷 Nancy, Meurthe-et-Moselle, France

Clairval's Hospital; 🇫🇷 Marseille, Bouches-du-Rhône, France

Toulouse University Hospital; 🇫🇷 Toulouse, Haute-Garonne, France

Amiens University Hospital; 🇫🇷 Amiens, Somme, France

Tours University Hospital; 🇫🇷 Tours, Indre-et-Loire, France

InselHospital Bern; 🇨🇭 Bern, Switzerland

Rouen University Hospital; 🇫🇷 Rouen, Seine-Maritime, France

Rennes University Hospital; 🇫🇷 Rennes, Ille-et-Vilaine, France

Brest University Hospital; 🇫🇷 Brest, Finistère, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, Gironde, France

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France

Reims University Hospital; 🇫🇷 Reims, Marne, France

Ste Anne's Hospital; 🇫🇷 Paris, Ile De France, France

Angers University Hospital; 🇫🇷 Angers, Maine Et Loire, France

AP-HP La Pitié-Salpêtrière Hospital; 🇫🇷 Paris, France

Creteil University Hospital; 🇫🇷 Créteil, Val-de-Marne, France

AP-HP Le Kremlin Bicêtre Hospital; 🇫🇷 Paris, France

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Rostchild Foundation Hospital; 🇫🇷 Paris, France