Unruptured Cerebral Aneurysm: Prediction of Evolution

NCT04578808 | Recruiting

• 1 other identifier: RC20_0012
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 21

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.

Conditions

Unruptured Intracranial Aneurysm

Keywords

Unruptured Cerebral Aneurysm; Aneurysm Prediction Growth; Unruptured Intracranial aneurysm

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Quality of life related to the growth of UIA.

  5 years

• AWE variation patterns related to the growth of UIA.

  5 years

• Clinical, genetics or biological factors related to the growth of UIA.

  5 years

• Incidence of growth of UIA.

  5 years

• Incidence of IA rupture

  5 years

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Centre Hospitalier St Anne: collaborator

Study Sites (21)

Clairval's Hospital

Marseille, Bouches-du-Rhône, 13000, France

RECRUITING

Brest University Hospital

Brest, Finistère, 29200, France

RECRUITING

Bordeaux University Hospital

Bordeaux, Gironde, 33000, France

RECRUITING

Toulouse University Hospital

Toulouse, Haute-Garonne, 31000, France

RECRUITING

Limoges University Hospital

Limoges, Haute-Vienne, 87000, France

RECRUITING

Rennes University Hospital

Rennes, Ille-et-Vilaine, 35000, France

RECRUITING

Tours University Hospital

Tours, Indre-et-Loire, 37000, France

RECRUITING

Nantes University Hospital

Nantes, Loire-Atlantique, 44000, France

RECRUITING

Angers University Hospital

Angers, Maine et Loire, 49000, France

RECRUITING

Reims University Hospital

Reims, Marne, 51100, France

NOT YET RECRUITING

Nancy University Hospital

Nancy, Meurthe-et-Moselle, 54000, France

RECRUITING

AP-HP La Pitié-Salpêtrière Hospital

Paris, Paris, 75000, France

RECRUITING

AP-HP Le Kremlin Bicêtre Hospital

Paris, Paris, 75000, France

RECRUITING

Rostchild Foundation Hospital

Paris, Paris, 75000, France

RECRUITING

Rouen University Hospital

Rouen, Seine-Maritime, 76000, France

RECRUITING

Amiens University Hospital

Amiens, Somme, 80000, France

RECRUITING

Creteil University Hospital

Créteil, Val-de-Marne, 94000, France

NOT YET RECRUITING

St Anne HIA

Toulon, France

RECRUITING

Ste Anne's Hospital

Paris, Île-de-France Region, 75674, France

RECRUITING

UMC Utrecht

Utrecht, 3500, Netherlands

RECRUITING

InselHospital Bern

Bern, 3000, Switzerland

NOT YET RECRUITING

Study Officials

• Romain BOURCIER, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BOURCIER, MD

CONTACT

33240165608; romain.bourcier@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 8, 2020
• Study Start: August 19, 2019
• Primary Completion (Estimated): March 15, 2031
• Study Completion (Estimated): March 15, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (19); NL (1); CH (1)