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Gadolinium-enhanced aneurysm wall imaging of unruptured intracranial aneurysms

Completed
Conditions
Unruptured intracranial aneurysm - protuberance of a blood vessel
10002363
Registration Number
NL-OMON41834
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

18 years or older.
Patient is diagnosed with one or more unruptured intracranial aneurysms confirmed on digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA).
Informed consent signed by subject.

Exclusion Criteria

Medical history of sever renal insufficiency: GFR<30ml/min/1.73m; nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy (NSF/NFD).
Gadolinium contrast allergy.
Pregnancy.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The presence (present/absent) of gadolinium-enhancement of the aneurysm wall on<br /><br>3 Tesla MR-angiography (MRA).<br /><br><br /><br>If evaluation of the first 15 patients results in the possibility of a<br /><br>semi-quantitative outcome endpoint for contrast enhancement<br /><br>(none/mild/severe/complete), we will discuss the use of this endpoint with the<br /><br>entire study group.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Determinants of gadolinium-enhancement:<br /><br>a. The use of anti-inflammatory drugs (including acetylsalicylic acid);<br /><br>b. Hypertension;<br /><br>c. The size of the aneurysm;<br /><br>d. The relation with smoking.</p><br>
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