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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01581385
First received: March 13, 2012
Last updated: July 23, 2014
Last verified: July 2014
  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 2018
Estimated Primary Completion Date: June 2018 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 23, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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 July 23, 2014