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

Terminated

Phase 4 Results N/A

Trial Description

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.

Trial Stopped: difficulties recruiting this population for study population

Conditions

Interventions

  • PET/CT imaging with F-18 fluorodeoxyglucose Radiation
    Intervention Desc: 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 1: Kind: Experimental
    Label: Image comparison and association
    ARM 2: Kind: Experimental
    Label: Nuclear imaging
    Description: PET/CT imaging with F-18 fluorodeoxyglucose

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Screening
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Plaque Inflammation 30 days No

Sponsors