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

NCT ID: NCT01236508

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-10-27

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:

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.

Conditions

TIA; Stroke; Carotid Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Nuclear imaging

PET/CT imaging with F-18 fluorodeoxyglucose

Group Type: EXPERIMENTAL

PET/CT imaging with F-18 fluorodeoxyglucose

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Terrence Ruddy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terrence Ruddy, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20100606-01H

Identifier Type: -

Identifier Source: org_study_id