nruptured Cerebral Aneurysm: prediction of evolution: a prospective multi-centre study

Recruiting

Conditions: Unruptured intracranial aneurysm - protuberance of a blood vessel in the brain
10002363

Registration Number: NL-OMON50892

Lead Sponsor: antes University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

- Subject carrying unruptured and untreated typical intracranial aneurysm of
bifurcation < 7mm.
- Ability to be followed-up 3 years,
- Age > 18 years old,
- Subject planned to have regular MRI scan in the context of the usual medical
follow-up of UIA (MRI scan planned at least at inclusion, at year 1 and at year
3).

Exclusion Criteria

- Mycotic, fusiform-shaped, or dissecting intracranial aneurysm, intracranial
aneurysm in relation with arteriovenous malformation.
- Unruptured intracranial aneurysm scheduled for preventive occlusion within 3
years.
- Family history of polycystic kidney disease, Ehlers-Danlos syndromes,
Marfan*s syndrome, or Moyamoya disease.
- Failure to obtain informed consent.
- MRI or constrast injection contraindication.
- Cavernous or partially thrombosed unruptured intracranial aneurysm.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In order to evaluate the predictive value of arterial wall enhancement for<br /><br>unruptured intracranial aneurysm growth, we will consider as primary endpoint<br /><br>the growth of the unruptured intracranial aneurysm after the complete follow-up<br /><br>at 3 years.<br /><br>This event could occur at any time during the follow-up if an unruptured<br /><br>intracranial aneurysm becomes symptomatic but will be systematically assessed<br /><br>at 1 year and 3 years by MRI.<br /><br>UIA growth will be assessed independently by two expert neuroradiologists,<br /><br>routinely involved in UIA management and disagreement will be solved by<br /><br>consensus with involvement of a third expert.<br /><br>UIA wall enhancement status will be defined independently by two different<br /><br>expert neuroradiologists, with > 5years experience in intracranial vessel wall<br /><br>imaging. Disagreement will be solved by consensus with involvement of a third<br /><br>expert.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Our secondary objectives are:<br /><br>- Determination of clinical and anatomical factors related to the growth of UIA.<br /><br>- Determination of clinical and anatomical factors related to rupture of UIA.<br /><br>- Detection of other arterial wall enhancement variation patterns related to<br /><br>growth during the follow-up in order to improve the follow-up of UIA patients.<br /><br><br /><br>Our secondary endpoints are:<br /><br>- Clinical and anatomical features recorded.<br /><br>- Incidence of growth, stratified by clinical and anatomical features.<br /><br>- Incidence of intracranial aneurysm rupture, stratified by clinical and<br /><br>anatomical features.<br /><br>- Construction and evaluation of an automatized tool of AWE patterns, as<br /><br>compared to the visual analysis of experts, in the form of a decision-making<br /><br>tool.</p><br>