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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02259257
• Date of registration: 23/09/2014
• Prospective Registration: Yes
• Primary sponsor: Diana Gaitini MD.
• Public title: 3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability CEUS carotid
• Scientific title: 3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability
• Date of first enrolment: November 2014
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02259257
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Steven B Feinstein, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- Subjects will be screened by asking each study subject if they have known or
suspected hypersensitivity to any of the components of Optison, blood, blood products
of albumin. In addition, each study subject will be asked if they have a right to
left or bi-directional or transient right to left cardiac shunts. If any of the above
questions are answered in the positive, the patient will not be eligible for
inclusion in the study.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atherosclerosis

Stroke

Primary Outcome(s)

Carotid plaque vascularization as seen on CEUS and histology compared to 3 year follow up of cardiovascular events. [Time Frame: Post processing of CEUS will be done up to 3 years post surgery]

Secondary ID(s)

226-14 RMB CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Technion, Israel Institute of Technology

Rush University