Ultrasound and Other Images of Artery Blockages

November 30, 2019 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Contrast-Enhanced Ultrasound Imaging of Carotid Plaque Neovascularization

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Vandana Sachdev, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 29, 2011

Study Completion

April 27, 2016

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 30, 2019

Last Verified

April 27, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110224
  • 11-H-0224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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