Status:
TERMINATED
Ultrasound and Other Images of Artery Blockages
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atherosclerosis
Eligibility:
All Genders
21+ years
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 ar...
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 advan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 29 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01419574
Start Date
July 29 2011
End Date
April 27 2016
Last Update
December 3 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892