Trial record 15 of 35 for:    Open Studies | carotid endarterectomy

Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
Information provided by (Responsible Party):
J. David Spence, Lawson Health Research Institute Identifier:
First received: October 18, 2011
Last updated: March 30, 2015
Last verified: March 2015

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.

Condition Intervention
Carotid Stenosis
Other: Histological validation

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

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Biospecimen Retention:   Samples Without DNA

Histological sections

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carotid endarterectomy patients
Patients scheduled for clinically indicated carotid endarterectomy
Other: Histological validation
3D ultrasound, PET/CT, MRI, contrast ultrasound

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients scheduled for carotid endarterectomy


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01456403

Contact: J. David Spence, M.D. 1-519-931-5731
Contact: Cathy Kelly, RN, CCCP 613-798-5555 ext 12979

Canada, Ontario
Robarts Research Institute Recruiting
London, Ontario, Canada, N6G2V4
Contact: Stroke Prevention & & Atherosclerosis Research Centre    1-519-931-5731   
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.         
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
Study Chair: J. David Spence, M.D. Robarts Research Institute, University of Western Ontario
  More Information

Additional Information:
Responsible Party: J. David Spence, Principal Investigator, Lawson Health Research Institute Identifier: NCT01456403     History of Changes
Other Study ID Numbers: CAIN-002
Study First Received: October 18, 2011
Last Updated: March 30, 2015
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Lawson Health Research Institute:
vulnerable plaque

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on May 21, 2015