Validation of CT angiography and MRI protocols to identify the different components of the atherosclerotic plaque in the carotid arteries compared to and histology.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- MRI Plaque quantification by basic morphological parameters (Plaque burden,
Lumen, Outer wall area) and plaque
composition (Fibrous cap, ulcerations, lipid rich necrotic core (LC/NR),
calcifications, intraplaque hemorrhage)
- Histology from the removed atherosclerotic plaque
Secondary outcome
NA
Background summary
Stroke is the third most important cause of death in the Western world and the
leading cause of permanent disability. Atherosclerotic disease in the carotid
bifurcation is in 20-30% of the cases responsible for ischemic stroke. The
majority of myocardial infarctions and stroke are due to an atherosclerotic
plaque that erodes or ruptures generating a thromboembolic event.
Cerebrovascular accidents like transient ischemic attack (TIA) and stroke are
related to the size of the stenosis in the internal carotid artery, in
symptomatic and asymptomatic patients. However in the past decade, it has been
recognized that plaque vulnerability is much more important than plaque size
for the development of acute events. The recognition of the role of the
vulnerable plaque in the development of cardiovascular events provides a novel
opportunity for improved risk assessment.
Multi-sequence MRI has the potential to identify and measure different
components of atherosclerotic plaque in the carotid arteries and to quantify
plaque volume and volume of different components.
Study objective
Validation of CT angiography and MRI protocols to identify the different
components of the atherosclerotic plaque in the carotid arteries compared to
and histology.
Study design
A single center observational diagnostic study.
Study burden and risks
Subjects in this study won*t be at risk due to the MRI examination. The only
burden that they will have is an MRI examination, which will take 40-45 minutes
of their time in total.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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,*)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23307.078.08 |