Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

Completed

• Conditions: Carotid Stenosis
• Interventions: Other: Histological validation

• Registration Number: NCT01456403
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy patients	Histological validation	Patients scheduled for clinically indicated carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
Histologic validation of preoperative imaging of vulnerable plaque	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.

Secondary Outcome Measures

Name	Time	Method
Prediction of cardiovascular events	2 years	Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images

Trial Locations

Locations (3)

Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Robarts Research Institute; 🇨🇦 London, Ontario, Canada