Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Western Ontario, Canada.
Recruitment status was  Recruiting
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: October 19, 2011
Last verified: October 2011

October 18, 2011
October 19, 2011
January 2010
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Complete list of historical versions of study NCT01456403 on ClinicalTrials.gov Archive Site
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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 fluorodeoxylgucose, 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.

Not Provided
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 Plaque
Other: Imaging
3D ultrasound, PET/CT, MRI, contrast ultrasound
Carotid endarterectomy patients
Patients scheduled for carotid endarterectomy; virtually all for symptomatic carotid stenosis
Intervention: Other: Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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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
Both
Not Provided
No
Contact: J. David Spence, M.D. 1-519-663-3113 dspence@robarts.ca
Contact: Joan Fleming, R.N. 1-519-663-3113 jfleming@robarts.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