Clinical trial NCT01456403: Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
Official title: Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Keywords: Carotid
endarterectomy
vulnerable plaque
Ultrasound
MRI
PET/CT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Western Ontario, Canada
First posted: 2011-10-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for carotid endarterectomy

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Histologic validation of preoperative imaging of vulnerable plaque
timeFrame: Cross-sectional
Secondary outcomes:
measure: Prediction of cardiovascular events
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Robarts Research Institute, University of Western Ontario
name: J. David Spence, M.D.
role: STUDY_CHAIR
References:
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.
citation: 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.
citation: 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.