Back to resultsRelation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
Primary Purpose
TIA, Stroke, Carotid Artery Stenosis
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PET/CT imaging with F-18 fluorodeoxyglucose
Sponsored by
About this trial
This is an interventional screening trial for TIA focused on measuring White Matter Hyperintensity, Stroke, Carotid Artery Plaque Inflammation, FDG PET, MRI, TIA
Eligibility Criteria
Inclusion Criteria:
- Age 60 or greater at time of enrollment
- Written informed consent from patient or legal representative
- Diagnosis of stroke or TIA made by a stroke specialist within 90 days and fulfilling the following criteria:
- A TIA must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours.
- A stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. Post event Modified Rankin Score of 2 or less.
- Stroke meets the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria for large artery atherosclerosis
- Carotid Doppler, CTA or MRA confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. Stenosis will be measured following the method used in NASCET for CTA and MRA. Carotid Doppler measurements will follow the criteria defined by the Society for Ultrasound consensus conference.
- 12 lead ECG or Holter monitor confirming the absence of atrial fibrillation.
Exclusion Criteria:
- TIA or stroke in the vertebrobasilar system
- Index event was primary hemorrhage
- History of intermittent atrial fibrillation
- Cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global LV dysfunction, congenital cardiac defect)
- Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans)
- Sinovenous thrombosis, endocarditis or hypercoagulable state
- Pacemaker, ICD or other contraindications to MRI
- Diminished Kidney Function
- Contraindication to radiation exposure (eg: pregnancy)
- Severe Claustrophobia
Sites / Locations
- The Ottawa Hospital, Civic Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nuclear imaging
Arm Description
PET/CT imaging with F-18 fluorodeoxyglucose
Outcomes
Primary Outcome Measures
Plaque Inflammation
The extent to which plaque inflammation, as measured by the extent of FDG uptake, contributes to the number of covert infarcts and the magnitude of white matter hyperintensity.
Secondary Outcome Measures
Full Information
NCT ID
NCT01236508
First Posted
November 5, 2010
Last Updated
April 21, 2017
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
The Ottawa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01236508
Brief Title
Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
Official Title
Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulties recruiting this population for study population
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 27, 2016 (Actual)
Study Completion Date
October 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
The Ottawa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that inflammation in carotid plaque is predictive of the extent of ischemic lesion burden on the brain and will add to risk stratification for individuals with carotid disease.
Detailed Description
Objectives:
To investigate the relationship of carotid inflammation, as measured by FDG positron emission tomography (PET) to standardized uptake value in atherosclerotic plaque, with the number of covert brain infarcts.
To investigate the relationship of FDG PET standardized uptake value with the relative volume of white matter hyperintensity.
To correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TIA, Stroke, Carotid Artery Stenosis
Keywords
White Matter Hyperintensity, Stroke, Carotid Artery Plaque Inflammation, FDG PET, MRI, TIA
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nuclear imaging
Arm Type
Experimental
Arm Description
PET/CT imaging with F-18 fluorodeoxyglucose
Intervention Type
Radiation
Intervention Name(s)
PET/CT imaging with F-18 fluorodeoxyglucose
Intervention Description
Dose of 5 MBq/kg F-18-FDG given to fasting participant. Nuclear whole body imaging starting at 3 hours post-injection. The relation of the PET/CT image results and both the number of covert brain infarcts and the extent of white matter MRI hyperintensity will be investigated.
Primary Outcome Measure Information:
Title
Plaque Inflammation
Description
The extent to which plaque inflammation, as measured by the extent of FDG uptake, contributes to the number of covert infarcts and the magnitude of white matter hyperintensity.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 or greater at time of enrollment
Written informed consent from patient or legal representative
Diagnosis of stroke or TIA made by a stroke specialist within 90 days and fulfilling the following criteria:
A TIA must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours.
A stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. Post event Modified Rankin Score of 2 or less.
Stroke meets the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria for large artery atherosclerosis
Carotid Doppler, CTA or MRA confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. Stenosis will be measured following the method used in NASCET for CTA and MRA. Carotid Doppler measurements will follow the criteria defined by the Society for Ultrasound consensus conference.
12 lead ECG or Holter monitor confirming the absence of atrial fibrillation.
Exclusion Criteria:
TIA or stroke in the vertebrobasilar system
Index event was primary hemorrhage
History of intermittent atrial fibrillation
Cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global LV dysfunction, congenital cardiac defect)
Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans)
Sinovenous thrombosis, endocarditis or hypercoagulable state
Pacemaker, ICD or other contraindications to MRI
Diminished Kidney Function
Contraindication to radiation exposure (eg: pregnancy)
Severe Claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Ruddy, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital, Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
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Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
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