Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
|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|