Ultrasound and Other Images of Artery Blockages
- Conditions
- Atherosclerosis
- Registration Number
- NCT01419574
- Brief Summary
Background:
- Treatments for partly blocked carotid arteries are determined by a person s symptoms and by tests that show how severe the blockage is. Studies show that the material that blocks an artery is more important in spotting future problems than how tight the blockage is. Researchers want to develop better imaging studies to find which blockages are more high-risk.
Objectives:
- To use imaging studies to look at high-risk carotid artery blockages.
Eligibility:
- Individuals at least 21 years of age whose ultrasound exams show a major carotid artery blockage.
Design:
* Participants will be screened with a medical history, physical exam, blood and urine tests, , an ultrasound scan and a magnetic resonance imaging (MRI) scan.
* Participants will have ultrasound and other scans to obtain pictures of the arteries. The scans will use drugs that may help study doctors get a better picture of the blood vessels and blockages.
* Participants will have followup phone calls yearly for 3 years. If a participant later has surgery to remove the blockage, the surgeon will save part of it for future study.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States