Validation of CT Angiography and Magnetic Resonance Imaging protocols for characterization and quantification of atherosclerosis in carotid arteries.

Completed

Conditions: atherosclerosis
10003216

Registration Number: NL-OMON39409

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

- Patients with cerebrovascular symptoms (TIA, minor stroke) in the last six
months.
- CTA of the carotid arteries at the Erasmus Medical Center during the last 2
months (CTA is performed for clinical work-up).
- Scheduled endarterectomy of a carotid artery
- Signed informed consent
- At least 50 years old
- Patients who have a documented allergy to MRI contrast media are eligible for MRI, but will not undergo a contrast-enhanced scan.
- Patients with a renal clearance (eGFR) <30 ml/minute are eligible for MRI, but will not undergo contrast-enhanced MRI.

Exclusion Criteria

- Woman who are pregnant or lactating.
- Patients who are hemodynamically unstable.
- Having any physical or mental status that interferes with the informed
consent procedure.
- Not being able to remain lying down for at least 40-45 min (e.g. patients with
unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
- Contraindications for MRI (e.g. claustrophobia, pacemaker,*)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- MRI Plaque quantification by basic morphological parameters (Plaque burden,<br /><br>Lumen, Outer wall area) and plaque<br /><br>composition (Fibrous cap, ulcerations, lipid rich necrotic core (LC/NR),<br /><br>calcifications, intraplaque hemorrhage)<br /><br>- Histology from the removed atherosclerotic plaque</p><br>

Secondary Outcome Measures