NCT01456403

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

October 18, 2011

Last Update Submit

September 6, 2016

Conditions

Carotid Stenosis

Keywords

Carotidendarterectomyvulnerable plaqueUltrasoundMRIPET/CT

Outcome Measures

Primary Outcomes (1)

  • Histologic validation of preoperative imaging of vulnerable plaque

    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.

    Cross-sectional

Secondary Outcomes (1)

  • Prediction of cardiovascular events

    2 years

Study Arms (1)

Carotid endarterectomy patients

Patients scheduled for clinically indicated carotid endarterectomy

Other: Histological validation

Interventions

Histological validationOTHER

3D ultrasound, PET/CT, MRI, contrast ultrasound

Carotid endarterectomy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for carotid endarterectomy

You may qualify if:

  • Scheduled for carotid endarterectomy; provided informed consent

You may not qualify if:

  • Those not eligible for some of the imaging modalities (for example, metal in body, renal dysfunction) are excluded from MRI imaging or CT angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Robarts Research Institute

London, Ontario, N6G2V4, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W77, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

  • Does Glucose Corrected [18F]fluorodeoxyglucose Uptake in Human Carotid Plaque Relate to the Extent of Inflammation on Immunohistology? Cocker M.S., Spence J.D., Hammond R., Mc Ardle B., deKemp R., Brennan J., Lum C., Yerofeyeva Y., Karavardanyan T., Adeeko A., Youssef G., Hill A., Stotts G., Renaud J.M., Alturkustani M., Hammond L., DaSilva J., Tardif J.C. and Beanlands R. American Heart Association Scientific Sessions. Los Angeles, United States. November 3 - 7, 2012. Circulation 2012: 126: A17612.

    BACKGROUND

  • Immunohistochemical Validation of [18F]-fluorodeoxyglucose as a Novel Biomarker of Inflamed Vulnerable Carotid Plaque: A Sub-study of the Canadian Atherosclerosis Imaging Network (CAIN). Cocker M.S., Mc Ardle B., deKemp R., Lum C., Youssef G., Hammond R., Yerofeyeva Y., Karavardanyan T., Adeeko A., Hill A., Stotts G., Sharma M., Renaud J.M., Brennan J., Alturkustani M., Hammond L., DaSilva J., Tardif J.C. Spence J.D., and Beanlands R. Canadian Cardiovascular Congress 2012. Toronto, Canada. October 26 - 31, 2012. Canadian Journal of Cardiology 2012: 28(5): S162.

    BACKGROUND

  • Cocker MS, Mc Ardle B, Spence JD, Lum C, Hammond RR, Ongaro DC, McDonald MA, Dekemp RA, Tardif JC, Beanlands RS. Imaging atherosclerosis with hybrid [18F]fluorodeoxyglucose positron emission tomography/computed tomography imaging: what Leonardo da Vinci could not see. J Nucl Cardiol. 2012 Dec;19(6):1211-25. doi: 10.1007/s12350-012-9631-9.

    PMID: 23073913RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological sections

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • J. David Spence, M.D.

    Robarts Research Institute, University of Western Ontario

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 20, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)