Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

Carotid Stenosis Clinical Trial

Official title:

Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456403
• Other study ID #: CAIN-002
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: September 6, 2016
• Start date: January 2011
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Other:
• Histological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound

Locations

Country	Name	City	State
Canada	Robarts Research Institute	London	Ontario
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 c — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic validation of preoperative imaging of vulnerable plaque	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	No
Secondary	Prediction of cardiovascular events	Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images	2 years	No

External Links

•   CAIN website
•   Stroke Prevention & Atherosclerosis Research Centre