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

Sponsor

Ottawa Heart Institute Research Corporation (Other)

Overall Status

Terminated

CT.gov ID

NCT01236508

Collaborator

The Ottawa Hospital (Other)

Enrollment

Location

Arm

71.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TIA Stroke Carotid Artery Stenosis	Radiation: PET/CT imaging with F-18 fluorodeoxyglucose	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Oct 27, 2016

Actual Study Completion Date :

Oct 27, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Plaque Inflammation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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