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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke; Carotid Artery Stenosis; TIA
• Intervention / Treatment: Radiation: PET/CT imaging with F-18 fluorodeoxyglucose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital, Civic Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: The Ottawa Hospital
• Investigators: Principal Investigator: Terrence Ruddy, MD, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 27, 2016
• Study Completion (Actual): October 27, 2016

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: MRI; Stroke; TIA; FDG PET; White Matter Hyperintensity; Carotid Artery Plaque Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Stroke; Inflammation; Carotid Stenosis; Leukoencephalopathies; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 20100606-01H