Unruptured Cerebral Aneurysm: Prediction of Evolution
ConditionUnruptured Intracranial Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Unruptured intracranial aneurysms
Other interventionUIA 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
5 years2
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.
Time frame
at 1 year3
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.
Time frame
at 3 yearsSecondary outcomes
1
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.
Time frame
5 years2
AWE variation patterns related to the growth of UIA.
Detection of other AWE variation patterns related to growth during the follow-up in order to improve the follow-up of UIA patients
Time frame
5 years3
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.
Time frame
5 years4
Incidence of growth of UIA.
Incidence of growth, stratified by clinical, genetics or biological features.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
Centre Hospitalier St Anne
Collaborator
Source ClinicalTrials.gov