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
  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 April 15, 2014