Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 95
- Locations
- 3
- Primary Endpoint
- Histologic validation of preoperative imaging of vulnerable plaque
Study Overview
Brief Summary
Patients scheduled for carotid endarterectomy undergo preoperative imaging to assess vulnerable plaque. The imaging modalities include (in various combinations at different study sites) 3-dimensional ultrasound, PET/CT imaging with fluorodeoxyglucose, MRI (3T)with gadolinium, and contrast ultrasound for assessment of neovascularity of plaques. At surgery the carotid endarterectomy is carried out with en bloc removal of the specimen, which is scanned and stained and assembled into 3D histology.
Detailed Description
Detailed Description: Patients will undergo 3D U/S and at least one other imaging method, PET/CTA or MRI, preoperatively. At some sites, some patients will also have an ultrasound with microbubbles. Following surgery, the carotid specimens will be transported to a central pathology lab for microcomputed tomographic imaging and further study.
At some sites patients will have a follow-up 3D U/S approximately 1 year after surgery to determine progression of plaque.
CAIN-2 sub-studies:
Eligible patients may be enrolled into one of the following sub-studies:
- CAIN-2 NaF pilot Characterizing Atherosclerotic Plaque with Sodium Fluoride Positron Emission Tomography- A Sub-Study of the Canadian Atherosclerosis Imaging Network (CAIN Project 2), - patients undergo sodium fluoride (NaF) PET/CT with CTA instead of FDG PET/CT preoperatively. All other imaging and study procedures are carried out as per the CAIN-2 study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for carotid endarterectomy; provided informed consent
Exclusion Criteria
- •Those not eligible for some of the imaging modalities (for example, metal in body, renal dysfunction) are excluded from MRI imaging or CT angiography
Outcomes
Primary Outcomes
Histologic validation of preoperative imaging of vulnerable plaque
Time Frame: Cross-sectional
3D histological images registered to the preoperative images of carotid plaques will be used to validate imaging features of plaque such as thin cap, intraplaque hemorrhage, large lipid core and inflammation.
Secondary Outcomes
- Prediction of cardiovascular events(2 years)
Investigators
J. David Spence
Principal Investigator
Lawson Health Research Institute