Histological Validation Of Carotid Plaque Composition In Preoperative Imaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by University of Western Ontario, Canada
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: May 16, 2014
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 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

Further study details as provided by University of Western Ontario, Canada:

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.

  Eligibility

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

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 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 ClinicalTrials.gov identifier: NCT01456403

Contacts
Contact: J. David Spence, M.D. 1-519-931-5731 dspence@robarts.ca
Contact: Cathy Kelly, RN, CCCP 613-798-5555 ext 12979 CKelly@ottawaheart.ca

Locations
Canada, Ontario
Robarts Research Institute Recruiting
London, Ontario, Canada, N6G2V4
Contact: Stroke Prevention & & Atherosclerosis Research Centre    1-519-931-5731    sparc@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.         
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: May 16, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Western Ontario, Canada:
Carotid
endarterectomy
vulnerable plaque
Ultrasound
MRI
PET/CT

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014