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Acoustic Radiation Force Impulse (ARFI) Ultrasound for Noninvasive, Diagnostic Atherosclerosis Imaging

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ClinicalTrials.gov Identifier: NCT01581385
Recruitment Status : Active, not recruiting
First Posted : April 20, 2012
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
This is a pilot clinical trial to assess the ability of a new ultrasound-based imaging method, Acoustic Radiation Force Impulse (ARFI) ultrasound, to describe the composition and structure of atherosclerotic plaques. The hypothesis being tested is that in vivo, transcutaneous ARFI ultrasound delineates plaque composition and structure in human carotid arteries.

Condition or disease
Atherosclerosis

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Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Acoustic Radiation Force Impulse (ARFI) Ultrasound for Noninvasive, Diagnostic Atherosclerosis Imaging; Independent Scientist: ARFI and RWI Ultrasound for Improved Atherosclerosis Imaging
Study Start Date : April 2012
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Groups and Cohorts
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Group/Cohort
Carotid endarterectomy
Adult patient volunteers, male and female, undergoing clinically indicated carotid endarterectomy surgery.


Outcome Measures
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Primary Outcome Measures :
  1. ARFI AUC score [ Time Frame: baseline ]
    Statistical area under the curve (AUC) scores will be calculated using trained readers and spatially matched pathologist's interpretation of histochemical data. AUC scores will be determined for each of the four ARFI beam sequences implemented in this study with respect to characterizing calcium deposits, lipid/necrotic core, fibrous caps, collagen deposits, elastin deposits, disrupted internal elastic lamina, and thrombus.


Secondary Outcome Measures :
  1. ARFI sensitivity [ Time Frame: baseline ]
    Statistical sensitivity will be calculated by assessing the average AUC curve across all readers for each of the four ARFI beam sequences implemented in this study with respect to characterizing calcium deposits, lipid/necrotic core, fibrous caps, collagen deposits, elastin deposits, disrupted internal elastic lamina, and thrombus.

  2. ARFI specificity [ Time Frame: baseline ]
    Statistical sensitivity will be calculated by assessing the average AUC curve across all readers for each of the four ARFI beam sequences implemented in this study with respect to characterizing calcium deposits, lipid/necrotic core, fibrous caps, collagen deposits, elastin deposits, disrupted internal elastic lamina, and thrombus.


Biospecimen Retention:   Samples Without DNA
Plaque specimens extracted during clinically indicated carotid endarterectomy surgery will be sectioned and histochemically processed.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (18 years or older) male and female patients scheduled to undergo clinically indicated carotid endarterectomy surgery.
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo clinically indicated carotid endarterectomy
  • Determination of clinical need for carotid endarterectomy will be made by the vascular surgeons on this protocol, but the general criteria include symptomatic carotid disease with a stenosis or lesion in the carotid artery thought to be the source of emboli or asymptomatic carotid artery disease with a > 60% internal carotid artery stenosis in the ipsilateral (surgical) artery.
  • Male or Female
  • >18 years of age with no upper limit
  • Ability to provide informed consent
  • Surgeon's approval
  • Any ethnicity or race (meeting all other criteria)

Exclusion Criteria:

  • Inability to communicate in English
  • Inability to provide valid consent
  • Inability to remain motionless for at least 15 minutes
  • Carotid arteries deeper than 35 mm

  • Pregnancy*

    • Pregnant women will be excluded from this study because carotid dissection is more likely than carotid plaque in women of child-bearing age.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581385


Locations
United States, North Carolina
The University of North Carolina at Chapel Hill Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Caterina M Gallippi, Ph.D. UNC Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01581385     History of Changes
Other Study ID Numbers: 09-1049
R01HL092944 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by University of North Carolina, Chapel Hill:
atherosclerosis
carotid artery
carotid endarterectomy

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases