Unruptured Cerebral Aneurysm: Prediction of Evolution

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Unruptured intracranial aneurysms
  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).

Первичные конечные точки

• 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. [Срок оценки: 5 years]
• Predictive value of UIA wall enhancement for UIA growth [Срок оценки: at 1 year]
• Predictive value of UIA wall enhancement for UIA growth [Срок оценки: at 3 years]

Вторичные конечные точки (7)

• Quality of life related to the growth of UIA. [Срок оценки: 5 years]
• AWE variation patterns related to the growth of UIA. [Срок оценки: 5 years]
• Clinical, genetics or biological factors related to the growth of UIA. [Срок оценки: 5 years]
• Incidence of growth of UIA. [Срок оценки: 5 years]
• Incidence of IA rupture [Срок оценки: 5 years]
• quality of life patients related to the growth of UIA. [Срок оценки: 5 years]
• Construction of an automatized tool of AWE pattern [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 27 центров

• Clairval's Hospital — Marseille
• Brest University Hospital — Brest
• Bordeaux University Hospital — Bordeaux
• Toulouse University Hospital — Toulouse
• Limoges University Hospital — Limoges
• Rennes University Hospital — Rennes
• Tours University Hospital — Tours
• Nantes University Hospital — Nantes
• … и ещё 19 центров

Нидерланды · 1 центр

• UMC Utrecht — Utrecht

Швейцария · 1 центр

• InselHospital Bern — Bern

Идентификаторы

NCT: NCT04578808 · RC20_0012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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