This trial is active, not recruiting.

Conditions tia, stroke, carotid artery stenosis
Treatment pet/ct imaging with f-18 fluorodeoxyglucose
Phase phase 4
Sponsor Ottawa Heart Institute Research Corporation
Collaborator The Ottawa Hospital
Start date November 2010
End date October 2018
Trial size 50 participants
Trial identifier NCT01236508, 20100606-01H


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
PET/CT imaging with F-18 fluorodeoxyglucose
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.

Primary Outcomes

Plaque Inflammation
time frame: 30 days

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
Principal investigator Terrence Ruddy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation.