Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
|ClinicalTrials.gov Identifier: NCT01456403|
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment|
|Carotid Stenosis||Other: Histological validation|
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.
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Carotid endarterectomy patients
Patients scheduled for clinically indicated carotid endarterectomy
Other: Histological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound
- 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.
- Prediction of cardiovascular events [ Time Frame: 2 years ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456403
|Robarts Research Institute|
|London, Ontario, Canada, N6G2V4|
|Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W77|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Study Chair:||J. David Spence, M.D.||Robarts Research Institute, University of Western Ontario|