3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability

NCT02259257 | Unknown

• 1 other identifier: 226-14 RMB CTIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of the dynamic vascular features of the plaques, in a unique spatial format using three orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature as viewed in various angles provides a realistic representation that is more easily appreciated. Inter-observer variability for individual plaques has been assessed and inter-observer variability and inter-scan variability (the analysis of multiple images from single patients in longitudinal studies) were dependent on plaque size, with larger plaques showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid plaque will provide added value for the depiction of the and quantification of intra-plaque blood vessel density by providing a true volumetric viewing area. This data will be correlated to the subsequent surgical specimens. The goal of the protocol is to investigate the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa vasorum using quantitative software analyses. The histology methods used for quantification of hemorrhage and vessel density analyses.

Conditions

Atherosclerosis; Stroke

Keywords

carotid arteriosclerosis; contrast-enhanced ultrasound; neovascularization; quantitative analysis; 3D/4D imaging; CEUS; Vasa vasorum

Outcome Measures

Primary Outcomes (1)

• Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events.

  Post processing of CEUS data for carotid plaque vascularization. In addition all carotid artery histology specimens, routinely obtained at the time of surgery at each center, will be analyzed to include the following tissue stains: CD3, CD31, CD38 and Hemosiderin.

  Post processing of CEUS will be done up to 3 years post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for endarterectomy due to carotid stenosis demonstrated on a previous imaging examination (exhibiting \>50% intra-luminal narrowing or a maximum IMT measurement of \> 1.5mm) or have experienced a CVA event (TIA/CVA) .

You may qualify if:

• Adult subjects with known carotid artery disease will be included.
• Subject must be able and willing to comply with study procedures and provide a signed and dated informed consent including consent for 3 year annual follow up.

You may not qualify if:

• Female subjects of child bearing potential will be excluded.
• The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
• History of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
• Has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
• Has known right to left, bi-directional or transient right to left cardiac shunts.
• Any known contra-indications as listed on the current Optison package insert.

Sponsors & Collaborators

• Diana Gaitini MD.: lead
• Technion, Israel Institute of Technology: collaborator
• Rush University: collaborator

Study Sites (1)

Rambam Health Care Center

Haifa, Haifa District, 31096, Israel

Location

Related Publications (6)

• Hoogi A, Adam D, Hoffman A, Kerner H, Reisner S, Gaitini D. Carotid plaque vulnerability: quantification of neovascularization on contrast-enhanced ultrasound with histopathologic correlation. AJR Am J Roentgenol. 2011 Feb;196(2):431-6. doi: 10.2214/AJR.10.4522.

  PMID: 21257897 BACKGROUND

• Staub D, Schinkel AF, Coll B, Coli S, van der Steen AF, Reed JD, Krueger C, Thomenius KE, Adam D, Sijbrands EJ, ten Cate FJ, Feinstein SB. Contrast-enhanced ultrasound imaging of the vasa vasorum: from early atherosclerosis to the identification of unstable plaques. JACC Cardiovasc Imaging. 2010 Jul;3(7):761-71. doi: 10.1016/j.jcmg.2010.02.007.

  PMID: 20633855 BACKGROUND

• Michel JB, Virmani R, Arbustini E, Pasterkamp G. Intraplaque haemorrhages as the trigger of plaque vulnerability. Eur Heart J. 2011 Aug;32(16):1977-85, 1985a, 1985b, 1985c. doi: 10.1093/eurheartj/ehr054. Epub 2011 Mar 12.

  PMID: 21398643 BACKGROUND

• Hellings WE, Peeters W, Moll FL, Piers SR, van Setten J, Van der Spek PJ, de Vries JP, Seldenrijk KA, De Bruin PC, Vink A, Velema E, de Kleijn DP, Pasterkamp G. Composition of carotid atherosclerotic plaque is associated with cardiovascular outcome: a prognostic study. Circulation. 2010 May 4;121(17):1941-50. doi: 10.1161/CIRCULATIONAHA.109.887497. Epub 2010 Apr 19.

  PMID: 20404256 BACKGROUND

• Sluimer JC, Daemen MJ. Novel concepts in atherogenesis: angiogenesis and hypoxia in atherosclerosis. J Pathol. 2009 May;218(1):7-29. doi: 10.1002/path.2518.

  PMID: 19309025 BACKGROUND

• Shah F, Balan P, Weinberg M, Reddy V, Neems R, Feinstein M, Dainauskas J, Meyer P, Goldin M, Feinstein SB. Contrast-enhanced ultrasound imaging of atherosclerotic carotid plaque neovascularization: a new surrogate marker of atherosclerosis? Vasc Med. 2007 Nov;12(4):291-7. doi: 10.1177/1358863X07083363.

  PMID: 18048465 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue: Carotid plaque histological specimen

MeSH Terms

Conditions

Atherosclerosis; Stroke; Carotid Artery Diseases; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Steven B Feinstein, MD

CONTACT

1-312-942-5000; Steven_Feinstein@rush.edu

Diana E Gaitini, MD

CONTACT

972-4-8542664; d_gaitini@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Ultrasound Unit, Dept of Medical Imaging

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 8, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2017
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

IL (1)