Ultrasound and Other Images of Artery Blockages

Stopped early

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT01419574

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

12

Starts

2011-07-29

Expected to finish

2016-04-27

Last updated by the study team

2019-12-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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