Status:
COMPLETED
Pilot Study of Ultrasonic Determined Carotid Plaque Composition
Lead Sponsor:
D. Geoffrey Vince
Collaborating Sponsors:
Siemens Medical Solutions
Conditions:
Atherosclerosis
Eligibility:
All Genders
40+ years
Brief Summary
Pilot prospective two group observational study to create a model of the carotid plaque composition based on ultrasonic backscattered signals and select clinical data.
Detailed Description
Stroke is a major cause of morbidity and mortality among patients with cardiovascular disease and the major cause of long-term disability in the United States. Current imaging modalities can determine...
Eligibility Criteria
Inclusion
- CEA Cohort:
- Age ≥40years
- Scheduled to undergo CEA for clinically significant carotid stenosis
- CEA is being performed for carotid stenosis of one or more of the following vessels: Internal Carotid Artery (ICA), distal end of the Common Carotid Artery (CCA), and/or CCA bulb.
Exclusion
- Pregnancy
- Prior surgery or intervention involving the carotid artery
- Prior stent in the carotid artery
- Unable to provide informed consent
- CEA for carotid stenosis for proximal CCA only (ICA and distal CCA are not involved)
- CEA is scheduled for non-atherosclerotic vascular disease (e.g.,. fibromuscular dysplasia or systemic vasculitis)
- Unable to understand English language.
- Normal Cohort:
- Inclusion Criteria
- Age ≥40years
- Exclusion Criteria
- Pregnancy
- Prior surgery or intervention involving the carotid artery (including CEA)
- Prior stent in the carotid artery
- Unable to provide informed consent
- Unable to understand English language.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01879397
Start Date
May 1 2013
End Date
February 27 2020
Last Update
July 14 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195