Carotid StenosisNCT01456403
Histological Validation Of Carotid Plaque Composition In Preoperative Imaging
An observational study of Carotid Stenosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Histological validation
- How many people
- 95 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2011to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for carotid endarterectomy
Who may be able to join
- Scheduled for carotid endarterectomy; provided informed consent
Who cannot join
- Those not eligible for some of the imaging modalities (for example, metal in body, renal dysfunction) are excluded from MRI imaging or CT angiography
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Robarts Research Institute
London, Ontario, N6G2V4
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W77
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy
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.
Read the 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:
- 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.
- 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.
- Conditions
- Carotid Stenosis
- Being tested
- Histological validation
- Keywords
- Carotid, endarterectomy, vulnerable plaque, Ultrasound, MRI, PET/CT
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histological validationOther
3D ultrasound, PET/CT, MRI, contrast ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Carotid endarterectomy patients | Patients scheduled for clinically indicated carotid endarterectomy Receives: Other: Histological validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Cross-sectional
Secondary outcomes (1)
Prediction of cardiovascular events
Occurrence of stroke, cardiovascular death, myocardial infarction or revascularization procedures by imaging features of vulnerable plaque in the baseline images
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada
- Responsible party
- Principal investigator, J. David Spence, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- J. David Spence, M.D., Study chair, Robarts Research Institute, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456403
- Sponsor's protocol ID
- CAIN-002
- Status last verified
- Sep 2016
- First submitted
- 18 Oct 2011
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
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.
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.
PubMed 23073913
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Validation Of Carotid Plaque Composition In Preoperative Imaging Of Patients Scheduled For Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT01456403
- Acronym / sponsor ID
- CAIN-002
- Conditions
- Carotid Stenosis
- Keywords
- Carotid, endarterectomy, vulnerable plaque, Ultrasound, MRI, PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid endarterectomy patients | – | Other: Histological validationPatients scheduled for clinically indicated carotid endarterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for carotid endarterectomy
Key inclusion criteria (1 listed)
- Scheduled for carotid endarterectomy; provided informed consent
Key exclusion criteria (1 listed)
- Those not eligible for some of the imaging modalities (for example, metal in body, renal dysfunction) are excluded from MRI imaging or CT angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histological validation3D ultrasound, PET/CT, MRI, contrast ultrasound | Other | Carotid endarterectomy patients |
Primary outcome
Histologic validation of preoperative imaging of vulnerable plaque
Time frame: Cross-sectional
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.
1 secondary outcome
Prediction of cardiovascular events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- BackgroundDoes 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.
- BackgroundImmunohistochemical 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.
- Results publication: PubMed 23073913Cocker 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.
- CAIN websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. David Spence, M.D. study chair
Robarts Research Institute, University of Western Ontario
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Stenosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic validation of preoperative imaging of vulnerable plaque (time frame: Cross-sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.