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Imaging of extracranial carotid aneurysms

Completed
Conditions
dilatation of the extracranial carotid artery
expansion of the neck artery
10002363
Registration Number
NL-OMON43210
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
15
Inclusion Criteria

Dutch patient registered in the carotid aneurysm registry
Willingness and ability to participate in all scheduled procedures outlined in the protocol.
Written informed consent

Exclusion Criteria

1. Subject registered in the CAR that have undergone surgical or endovascular treatment of the ECAA.
2. Patients with contraindications for CTA such as:
1) severe renal insufficiency (GFR<30ml/min/ 1.73m2) or nephrogenic systemic fibrosis/nephrogenic fibrosing nephropathy; 2) contrast allergy, and 3) pregnancy.
3. Contraindications for 3T MRI, such as 1) pacemaker or metal object in or around the body; 2)claustrophobia, 3) severe renal insufficiency (GFR<30ml/min/ 1.73m2) or nephrogenic systemic fibrosis / nephrogenic fibrosing nephropathy; and 4) pregnancy.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Observational study: differences in diameter measurements using 3T MRI and CTA<br /><br>will be assed.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- The inter-rater reliability and intra-observer agreement of volume<br /><br>measurement in ECAA using CTA with 3D reconstruction at baseline and 1 year<br /><br>after baseline measured by two independent observers blinded for previous<br /><br>imaging.<br /><br>- Aneurysm diameter growth (defined as at least 3mm growth in largest diameter<br /><br>of the aneurysm) on 3T MRI between baseline and 1 year after baseline measured<br /><br>by two independent observers blinded for previous imaging.<br /><br>- Degree of gadolium enhancement in the ECAA wall on 3T MRI (categorized into<br /><br>no, moderate or severe enhancements). 3T MRI will be read by two independent<br /><br>observers blinded for patient data and previous imaging.<br /><br>- Correlation between gadolium enhancement and aneurysm growth on 3T MRI.<br /><br>- Prevalence of white matter abnormalities on 3T MRI.</p><br>
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