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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT01581385

First received: March 13, 2012

Last updated: February 12, 2016

Last verified: February 2016

History of Changes

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:

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

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.


Enrollment:	25
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 (Adult, Senior)
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

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


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:	February 12, 2016
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 September 23, 2016

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