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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 18, 2011 | ||||||||
| Last Updated Date | October 19, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01456403 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Histological Validation Of Carotid Plaque Composition In Preoperative Imaging | ||||||||
| Official Title ICMJE | HISTOLOGICAL VALIDATION OF CAROTID PLAQUE COMPOSITION IN PREOPERATIVE IMAGING OF 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 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Histological sections |
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients scheduled for carotid endarterectomy |
||||||||
| Condition ICMJE | Carotid Plaque | ||||||||
| Intervention ICMJE | Other: Imaging
3D ultrasound, PET/CT, MRI, contrast ultrasound |
||||||||
| Study Group/Cohort (s) | Carotid endarterectomy patients
Patients scheduled for carotid endarterectomy; virtually all for symptomatic carotid stenosis
Intervention: Other: Imaging |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01456403 | ||||||||
| Other Study ID Numbers ICMJE | CAIN-002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Western Ontario, Canada | ||||||||
| Study Sponsor ICMJE | University of Western Ontario, Canada | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of Western Ontario, Canada | ||||||||
| Verification Date | October 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||