Optimal early recognition of persons at high risk of aneurysmal subarachnoid haemorrhage

Completed

Conditions: Intracranial aneurysm
10007963
10002363

Registration Number: NL-OMON55759

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 500

Inclusion Criteria

- Age between 20 and 70 years
- At least one first degree relative with an unruptured intracranial aneurysm
identified by MRA, CTA or conventional angiography

Exclusion Criteria

- People who do not speak Dutch well enough to give informed consent
- Any first degree relative with an aneurysmal subarachnoid hemorrhage
- A history of an aneurysmal subarachnoid hemorrhage and/or unruptured
intracranial aneurysm
- A history of polycystic kidney disease, Ehlers-Danlos, or fibromuscular
dysplasia
- Relative contraindication(s) for MRA, e.g. pregnancy, an internal metal
device such as a pacemaker, or claustrophobia
- A serious condition that would interfere with the treatment of an UIA, e.g.
severe comorbidity or reduced life expectancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective 1)<br /><br>- the prevalence of UIA in persons with >=1 FDR with an UIA<br /><br><br /><br>Objective 2)<br /><br>- the prevalence of potential risk factors for UIA development in persons with<br /><br>>=1 FDR with an UIA<br /><br><br /><br>Objective 3)<br /><br>- the prevalence of UIA in persons with >=1 FDR with an UIA</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Objective 1)<br /><br>- costs of screening for and preventive treatment of UIA<br /><br>- clinical outcome after preventive treatment of an UIA identified with<br /><br>screening<br /><br>- decision model studying cost-effectiveness expressed in costs per QALY<br /><br><br /><br>Objective 2)<br /><br>- prediction model of risk of UIA in persons with >=1 FDR with an UIA<br /><br><br /><br>Objective 3)<br /><br>- correlation of imaging markers on 3T and 7T MRA and biopsy findings of the<br /><br>UIA wall </p><br>