- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456403
Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy
Study Overview
Status
Conditions
Intervention / Treatment
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.
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6G2V4
- Robarts Research Institute
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Ottawa, Ontario, Canada, K1Y 4W77
- Ottawa Heart Institute
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Carotid endarterectomy patients
Patients scheduled for clinically indicated carotid endarterectomy
|
3D ultrasound, PET/CT, MRI, contrast ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Cross-sectional
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: J. David Spence, M.D., Robarts Research Institute, University of Western Ontario
Publications and helpful links
General Publications
- Does Glucose Corrected [18F]fluorodeoxyglucose Uptake in Human Carotid Plaque Relate to the Extent of Inflammation on Immunohistology? Cocker M.S., Spence J.D., Hammond R., Mc Ardle B., deKemp R., Brennan J., Lum C., Yerofeyeva Y., Karavardanyan T., Adeeko A., Youssef G., Hill A., Stotts G., Renaud J.M., Alturkustani M., Hammond L., DaSilva J., Tardif J.C. and Beanlands R. American Heart Association Scientific Sessions. Los Angeles, United States. November 3 - 7, 2012. Circulation 2012: 126: A17612.
- Immunohistochemical Validation of [18F]-fluorodeoxyglucose as a Novel Biomarker of Inflamed Vulnerable Carotid Plaque: A Sub-study of the Canadian Atherosclerosis Imaging Network (CAIN). Cocker M.S., Mc Ardle B., deKemp R., Lum C., Youssef G., Hammond R., Yerofeyeva Y., Karavardanyan T., Adeeko A., Hill A., Stotts G., Sharma M., Renaud J.M., Brennan J., Alturkustani M., Hammond L., DaSilva J., Tardif J.C. Spence J.D., and Beanlands R. Canadian Cardiovascular Congress 2012. Toronto, Canada. October 26 - 31, 2012. Canadian Journal of Cardiology 2012: 28(5): S162.
- Cocker MS, Mc Ardle B, Spence JD, Lum C, Hammond RR, Ongaro DC, McDonald MA, Dekemp RA, Tardif JC, Beanlands RS. Imaging atherosclerosis with hybrid [18F]fluorodeoxyglucose positron emission tomography/computed tomography imaging: what Leonardo da Vinci could not see. J Nucl Cardiol. 2012 Dec;19(6):1211-25. doi: 10.1007/s12350-012-9631-9.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIN-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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