Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by University of Western Ontario, Canada
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01456403
First received: October 18, 2011
Last updated: May 16, 2014
Last verified: October 2011

October 18, 2011
May 16, 2014
January 2011
July 2015   (final data collection date for primary outcome measure)
Histologic validation of preoperative imaging of vulnerable plaque [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01456403 on ClinicalTrials.gov Archive Site
Prediction of cardiovascular events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images
Not Provided
Not Provided
Not Provided
 
Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
HISTOLOGICAL VALIDATION OF CAROTID PLAQUE COMPOSITION IN PREOPERATIVE IMAGING OF PATIENTS SCHEDULED FOR CAROTID ENDARTERECTOMY

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: 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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Histological sections

Non-Probability Sample

Patients scheduled for carotid endarterectomy

Carotid Stenosis
Other: Histological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound
Carotid endarterectomy patients
Patients scheduled for clinically indicated carotid endarterectomy
Intervention: Other: Histological validation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: J. David Spence, M.D. 1-519-931-5731 dspence@robarts.ca
Contact: Cathy Kelly, RN, CCCP 613-798-5555 ext 12979 CKelly@ottawaheart.ca
Canada
 
NCT01456403
CAIN-002
Yes
University of Western Ontario, Canada
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Study Chair: J. David Spence, M.D. Robarts Research Institute, University of Western Ontario
University of Western Ontario, Canada
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP