Contrast-Enhanced Ultrasound Imaging of Carotid Plaque Neovascularization
21 Years
N/A
Both
Carotid Artery Plaque
Trial Information
Contrast-Enhanced Ultrasound Imaging of Carotid Plaque Neovascularization
Traditional evaluations of atherosclerotic disease in the carotid arteries and treatment
recommendations have focused primarily on degree of obstruction. Emerging data from
histologic series and advanced imaging studies suggests that anatomic features related to
plaque biology, including inflammation, lipid accumulation, and angiogenesis, may be used to
detect vulnerable plaques more likely to cause clinical effects. Contrast-enhanced
ultrasound (CEUS) is a new technique that uniquely visualizes intraplaque
neovascularization. Magnetic resonance imaging (MRI) of carotid plaque lipid core and
intraplaque hemorrhage has shown value in the prediction of future neurologic events. We
propose a multimodal approach to assess plaque activity in subjects with known carotid
disease using CEUS, MRI imaging, and serum biomarker evaluation. In subjects undergoing
carotid endarterectomy, imaging findings will be validated by histology. Both imaging and
histologic findings will be compared with prospective cardiovascular events.
Inclusion Criteria
- INCLUSION CRITERIA:
Inclusion Criteria for Group A:
- Adult subjects age greater than or equal to 21 years
- Able to give written informed consent
- Prior clinical ultrasound exam showing a carotid stenosis of greater than or equal to
50 percent
Inclusion Criteria for Group B:
- Adult subjects age greater than or equal to 21 years
- Able to give written informed consent
- Prior clinical ultrasound exam showing a carotid stenosis suspected of causing
symptoms and/or clinical recommendation to undergo carotid endarterectomy
EXCLUSION CRITERIA:
- Atrial fibrillation or other irregular rhythm that would preclude adequate image
acquisition
- Subjects with a contraindication for the ultrasound contrast agent.
- Subjects with pacemakers, defibrillators, cerebral aneurysm clips, neural
stimulators, ear implants or other clinical contra-indications for magnetic resonance
scanning will be excluded from the MRI portion of the study.
- Subjects with an estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73
m(2) body surface area will be excluded from the contrast MRI portion of the study
but will still undergo non-contrast imaging.
- The eGFR will be used to estimate renal function if reported by the laboratory.
Otherwise, estimated glomerular filtration rate (eGFR) can be based on the
Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects
with stable renal function. This formula is not applicable to subjects with acute
renal insufficiency: eGFR (ml/min/1.73 m(2)) equal to 175 times (serum
creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times
1.212 (if the subject is black).
- Pregnant or lactating women
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Principal Investigator
Vandana Sachdev, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Heart, Lung, and Blood Institute (NHLBI)
Authority:
United States: Federal Government
Study ID:
110224
NCT ID:
NCT01419574
Start Date:
July 2011
Completion Date:
Related Keywords:
- Carotid Artery Plaque
- Carotid Artery Plaque
- Contrast Agents
- Vasa Vasorum
- MRI
- Intraplaque Hemorrhage
- Solid Tumor
- Metastatic Solid Tumor
- Carotid Stenosis
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
