The assessment of the Plaque at RISK by non-invasive (molecular) imaging and modelling (ParisK): Validation of imaging techniques with histology

Completed

Conditions: atherosclerotic plaque
hardening of the arteries
10003216

Registration Number: NL-OMON39382

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 71

Inclusion Criteria

- Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
- age 18 years or older (no maximum age)
- informed consent by signing informed consent form regarding this study
- inclusion criteria carotid endarterectomy:
* symptomatic carotid artery stenosis 70-99% within 3 months of neurologic symptoms
* symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurologic symptoms
* asymptomatic carotid artery stenosis 70-99% with contralateral occlusion

Exclusion Criteria

* Severe co-morbidity, dementia or pregnancy
* Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
* Patients who have a documented allergy to MRI or CT contrast media
* Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
* Patients with a renal clearance <60 ml/min are not eligible to undergo dual-energy CT

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- MRI: correlation between neovascularisation in carotid atherosclerotic plaque<br /><br>characteristics assessed by dynamic 3.0 Tesla MRI and carotid atherosclerotic<br /><br>plaque at histology.<br /><br>- CT: correlation between size of lipid-rich-necrotic-core in dual-energy CT<br /><br>and histology. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- MRI: correlation between volume of LRNC, fibrous cap status, and volume of<br /><br>calcifications in carotid atherosclerotic plaques visualised by MRI and carotid<br /><br>atherosclerotic plaques at histology.<br /><br>- Ultrasound: correlation between deformation pattern and plaque composition<br /><br>and volume of LRNC at histology.<br /><br>- TCD: relation between number of recorded MES and fibrous cap status.</p><br>