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

University of Ottawa Heart Institute

Status and phase

Terminated

Phase 4

Conditions

TIA

Carotid Artery Stenosis

Stroke

Treatments

Radiation: PET/CT imaging with F-18 fluorodeoxyglucose

Study type

Interventional

Funder types

Other

Identifiers

NCT01236508

20100606-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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