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Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease

This study has been terminated.
(difficulties recruiting this population for study population)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236508
First Posted: November 8, 2010
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Terrence Ruddy, Ottawa Heart Institute Research Corporation
  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: None (Open Label)
Primary Purpose: Screening
Official Title: Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease

Resource links provided by NLM:


Further study details as provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Plaque Inflammation [ Time Frame: 30 days ]
    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
Study Completion Date: October 27, 2016
Primary Completion Date: October 27, 2016 (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:

  1. 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.
  2. To investigate the relationship of FDG PET standardized uptake value with the relative volume of white matter hyperintensity.
  3. To correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.
  Eligibility

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236508


Locations
Canada, Ontario
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
The Ottawa Hospital
Investigators
Principal Investigator: Terrence Ruddy, MD The Ottawa Hospital
  More Information

Responsible Party: Terrence Ruddy, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT01236508     History of Changes
Other Study ID Numbers: 20100606-01H
First Submitted: November 5, 2010
First Posted: November 8, 2010
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by Terrence Ruddy, Ottawa Heart Institute Research Corporation:
White Matter Hyperintensity
Stroke
Carotid Artery Plaque Inflammation
FDG PET
MRI
TIA

Additional relevant MeSH terms:
Stroke
Inflammation
Carotid Stenosis
Leukoencephalopathies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Carotid Artery Diseases
Arterial Occlusive Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action