Clinical trial NCT04578808: Unruptured Cerebral Aneurysm: Prediction of Evolution
Official title: Unruptured Cerebral Aneurysm: Prediction of Evolution
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unruptured Intracranial Aneurysm
Keywords: Unruptured Cerebral Aneurysm
Aneurysm Prediction Growth
Unruptured Intracranial aneurysm
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier St Anne
First posted: 2020-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 5 years
measure: Predictive value of UIA wall enhancement for UIA growth
timeFrame: at 1 year
measure: Predictive value of UIA wall enhancement for UIA growth
timeFrame: at 3 years
Secondary outcomes:
measure: Quality of life related to the growth of UIA.
timeFrame: 5 years
measure: AWE variation patterns related to the growth of UIA.
timeFrame: 5 years
measure: Clinical, genetics or biological factors related to the growth of UIA.
timeFrame: 5 years
measure: Incidence of growth of UIA.
timeFrame: 5 years
measure: Incidence of IA rupture
timeFrame: 5 years
measure: quality of life patients related to the growth of UIA.
timeFrame: 5 years
measure: Construction of an automatized tool of AWE pattern
timeFrame: 5 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clairval's Hospital
state: Bouches-du-Rhône
city: Brest
country: France
facility: Brest University Hospital
state: Finistère
city: Bordeaux
country: France
facility: Bordeaux University Hospital
state: Gironde
city: Toulouse
country: France
facility: Toulouse University Hospital
state: Haute-Garonne
city: Limoges
country: France
facility: Limoges University Hospital
state: Haute-Vienne
city: Paris
country: France
facility: Ste Anne's Hospital
state: Ile De France
city: Rennes
country: France
facility: Rennes University Hospital
state: Ille-et-Vilaine
city: Tours
country: France
facility: Tours University Hospital
state: Indre-et-Loire
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
city: Angers
country: France
facility: Angers University Hospital
state: Maine Et Loire
city: Reims
country: France
facility: Reims University Hospital
state: Marne
city: Nancy
country: France
facility: Nancy University Hospital
state: Meurthe-et-Moselle
city: Rouen
country: France
facility: Rouen University Hospital
state: Seine-Maritime
city: Amiens
country: France
facility: Amiens University Hospital
state: Somme
city: Créteil
country: France
facility: Creteil University Hospital
state: Val-de-Marne
city: Paris
country: France
facility: AP-HP La Pitié-Salpêtrière Hospital
city: Paris
country: France
facility: AP-HP Le Kremlin Bicêtre Hospital
city: Paris
country: France
facility: Rostchild Foundation Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Bern
country: Switzerland
facility: InselHospital Bern
Study officials:
affiliation: Nantes University Hospital
name: Romain BOURCIER, MD
role: PRINCIPAL_INVESTIGATOR
References: