Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
This study is currently recruiting participants.
Verified October 2011 by University of Western Ontario, Canada
Sponsor:
University of Western Ontario, Canada
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carotid Plaque |
Other: Imaging |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | HISTOLOGICAL VALIDATION OF CAROTID PLAQUE COMPOSITION IN PREOPERATIVE IMAGING OF PATIENTS SCHEDULED FOR CAROTID ENDARTERECTOMY |
Further study details as provided by University of Western Ontario, Canada:
Biospecimen Retention: Samples Without DNA
Histological sections
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Carotid endarterectomy patients
Patients scheduled for carotid endarterectomy; virtually all for symptomatic carotid stenosis
|
Other: Imaging
3D ultrasound, PET/CT, MRI, contrast ultrasound
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients scheduled for carotid endarterectomy
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456403
Contacts
| 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 |
Locations
| Canada, Alberta | |
| University of Calgary | Not yet recruiting |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Principal Investigator: Richard Frayne, Ph.D. | |
| Canada, Ontario | |
| Robarts Research Institute | Recruiting |
| London, Ontario, Canada, N6G2V4 | |
| Contact: Joan Fleming, R.N. 1-519-663-3113 jfleming@robarts.ca | |
| Principal Investigator: J. David Spence, M.D. | |
| Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4W77 | |
| Principal Investigator: Robert Beanlands, M.D. | |
| Sub-Investigator: Rob DeKemp, Ph.D. | |
| Sunnybrook Health Sciences Centre | Not yet recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: Allan Moody, M.D. | |
| Canada, Quebec | |
| Montreal Heart Institute | Not yet recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Principal Investigator: Jean-Claude Tardif, M.D. | |
Sponsors and Collaborators
University of Western Ontario, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
| Study Chair: | J. David Spence, M.D. | Robarts Research Institute, University of Western Ontario |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Western Ontario, Canada |
| ClinicalTrials.gov Identifier: | NCT01456403 History of Changes |
| Other Study ID Numbers: | CAIN-002 |
| Study First Received: | October 18, 2011 |
| Last Updated: | October 19, 2011 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by University of Western Ontario, Canada:
|
Carotid endarterectomy vulnerable plaque |
Ultrasound MRI PET/CT |
ClinicalTrials.gov processed this record on May 19, 2013