Study to investigate the sensitivity and specificity of 3.0 Tesla MRI, MRS and ultrasound imaging for carotid artery plaque dimension and composition assessment.
- Conditions
- atherosclerosisn/a10003216
- Registration Number
- NL-OMON36476
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
carotid artery stenosis, > 70 %, scheduled for carotid endarterectomy
Exclusion Criteria
Not suitable for MRI (e.g. metal in the body, e.g. as a result of pacemaker or artificial cardiac valve implant), claustrophobia, former surgical procedures in the carotid area
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Imaging<br /><br><br /><br>1. Total plaque volume, plaque calcification volume, plaque haemorrhage<br /><br>volume, lipid rich necrotic core volume, fibrous cap thickness, as assessed by<br /><br>3.0 Tesla MRI.<br /><br>2. The ratio of the integrated lipid peak versus the unsuppressed water peak<br /><br>(expressed as a percentage), as assessed by MRS.<br /><br>3. Carotid plaque presence and location, maximum plaque thickness and plaque<br /><br>composition, as assessed by B-mode ultrasound imaging.<br /><br>4. Carotid intima-media thickness, arterial stiffness, blood flow velocity<br /><br>measured by ultrasound imaging.<br /><br><br /><br>Histology<br /><br><br /><br>5. Plaque size, morphology and phenotype (presence of collagen, smooth muscle<br /><br>cells, calcifications, macrophages, thrombus and fat), as assessed by histology<br /><br>analysis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>no secundary study parameters</p><br>