Carotid Stenosis
Conditions
Keywords
Carotid, endarterectomy, vulnerable plaque, Ultrasound, MRI, PET/CT
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: 1. 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. Recruitment for this pilot study is complete. 2. CAIN-2B Atherosclerotic plaque imaging using NaF and FDG imaging: Validation and Evaluation of Disease Progression. A sub-study of the Canadian Atherosclerosis Imaging Network (CAIN-2) Histopathology Validation study - patients undergo both NaF and FDG PET/CT preoperatively. All other imaging and study procedures are carried out as per the CAIN-2 study. A total of 45 patients will be enrolled in this sub-study. Eligibility criteria for the sub-studies is identical to the CAIN-2 criteria.
Interventions
OTHERHistological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histologic validation of preoperative imaging of vulnerable plaque | 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
| Measure | Time frame | Description |
|---|---|---|
| Prediction of cardiovascular events | 2 years | Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images |
Countries
Canada
Outcome results
None listed