Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||HISTOLOGICAL VALIDATION OF CAROTID PLAQUE COMPOSITION IN PREOPERATIVE IMAGING OF PATIENTS SCHEDULED FOR CAROTID ENDARTERECTOMY|
- Histologic validation of preoperative imaging of vulnerable plaque [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]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.
- Prediction of cardiovascular events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Carotid endarterectomy patients
Patients scheduled for clinically indicated carotid endarterectomy
Other: Histological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound
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.
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.
Recruitment for this pilot study is complete.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456403
|Contact: J. David Spence, M.D.||firstname.lastname@example.org|
|Contact: Cathy Kelly, RN, CCCP||613-798-5555 ext 12979||CKelly@ottawaheart.ca|
|Robarts Research Institute||Recruiting|
|London, Ontario, Canada, N6G2V4|
|Contact: Stroke Prevention & & Atherosclerosis Research Centre 1-519-931-5731 email@example.com|
|Principal Investigator: J. David Spence, M.D.|
|Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W77|
|Principal Investigator: Robert Beanlands, M.D.|
|Sub-Investigator: Rob DeKemp, Ph.D.|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator: Allan Moody, M.D.|
|Study Chair:||J. David Spence, M.D.||Robarts Research Institute, University of Western Ontario|