Risk of Aneurysm Rupture (ROAR) Study: measuring the rupture risk of unruptured intracranial aneurysms in the UK

Not Applicable

• Conditions: nruptured intracranial aneurysms; Circulatory System

• Registration Number: ISRCTN17658526
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2022-070504 (added 20/03/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-21
• Last Update Posted: 29 July 2024
• Study Completion: 2034-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

1. Intracranial intradural unruptured aneurysm, confirmed on angiogram (Computed Tomography Angiogram [CTA], Magnetic Resonance Angiography [MRA], Digital Subtraction Angiography [DSA])
2. Diagnosis of Unruptured Intracranial Aneurysm [UIA] between January 2006-December 2020.

Exclusion Criteria

1. Mycotic or vasculitic aneurysms
2. Aneurysm diagnosed on computed tomography (CT) or magnetic resonance imaging (MRI) alone
3. Arteriovenous malformation (AVM) associated flow aneurysms
4. Extradural aneurysms (e.g. intra-cavernous)
5. Aneurysms previously treated by either microsurgical or endovascular techniques
6. Small lesions uncertain as to whether they are truly aneurysmal (dilatation”, bulge”, ‘Infundibulum”)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rupture of a previously diagnosed unruptured intra-cranial aneurysm demonstrated on CT imaging or sections 1a-c on a death certificate after aneurysm diagnosis

Secondary Outcome Measures

Name	Time	Method
Growth of an unruptured intracranial aneurysm demonstrated on angiographic imaging after diagnosis