Acoustic Radiation Force Impulse (ARFI) Ultrasound for Noninvasive, Diagnostic Atherosclerosis Imaging
This study is currently recruiting participants.
Verified November 2012 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01581385
First received: March 13, 2012
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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 |
|---|
|
Atherosclerosis |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- ARFI AUC score [ Time Frame: baseline ] [ Designated as safety issue: No ]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:
- ARFI sensitivity [ Time Frame: baseline ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 16 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Carotid endarterectomy
Adult patient volunteers, male and female, undergoing clinically indicated carotid endarterectomy surgery.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581385
Contacts
| Contact: Melrose W Fisher, RN, BSN | 919-819-9054 | mwfisher@nc.rr.com |
| Contact: Caterina M Gallippi, Ph.D. | 919-843-6647 | cmgallip@bme.unc.edu |
Locations
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill Hospitals | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Caterina M Gallippi, Ph.D. | UNC Chapel Hill |
More Information
No publications provided
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01581385 History of Changes |
| Other Study ID Numbers: | 09-1049, R01HL092944 |
| Study First Received: | March 13, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 19, 2013