Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
This study is currently recruiting participants.
Verified February 2013 by University of Ottawa Heart Institute
Sponsor:
University of Ottawa Heart Institute
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Terrence Ruddy, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01236508
First received: November 5, 2010
Last updated: February 27, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
TIA Stroke Carotid Artery Stenosis |
Radiation: PET/CT imaging with F-18 fluorodeoxyglucose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease |
Further study details as provided by University of Ottawa Heart Institute:
Primary Outcome Measures:
- Plaque Inflammation [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nuclear imaging
PET/CT imaging with F-18 fluorodeoxyglucose
|
Radiation: PET/CT imaging with F-18 fluorodeoxyglucose
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.
|
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236508
Contacts
| Contact: Marlie A. Poirier, BScN, CCRP | 613-761-5103 | mpoirier@ottawaheart.ca |
Locations
| Canada, Ontario | |
| The Ottawa Hospital, Civic Campus | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Marlie A. Poirier, BScN, CCRP 613-761-5103 mpoirier@ottawaheart.ca | |
| Principal Investigator: Terrence Ruddy, MD | |
Sponsors and Collaborators
University of Ottawa Heart Institute
The Ottawa Hospital
Investigators
| Principal Investigator: | Terrence Ruddy, MD | The Ottawa Hospital |
More Information
No publications provided
| Responsible Party: | Terrence Ruddy, Principal Investigator, University of Ottawa Heart Institute |
| ClinicalTrials.gov Identifier: | NCT01236508 History of Changes |
| Other Study ID Numbers: | 20100606-01H |
| Study First Received: | November 5, 2010 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Ottawa Heart Institute:
|
White Matter Hyperintensity Stroke Carotid Artery Plaque Inflammation |
FDG PET MRI TIA |
Additional relevant MeSH terms:
|
Carotid Stenosis Inflammation Stroke Cerebral Infarction Leukoencephalopathies Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Deoxyglucose Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013