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
: April 19, 2017
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Condition or disease |
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Atherosclerosis |

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 : | June 2018 |
Estimated Study Completion Date : | June 2018 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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Pregnancy*
- Pregnant women will be excluded from this study because carotid dissection is more likely than carotid plaque in women of child-bearing age.

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
United States, North Carolina | |
The University of North Carolina at Chapel Hill Hospitals | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Caterina M Gallippi, Ph.D. | UNC Chapel Hill |
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: | April 19, 2017 |
Last Verified: | April 2017 |
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 |