Vascular Inflammation in Patients at Risk for
Atherosclerotic Disease

Subjects at risk

Patients must meet the following criteria for study entry: Patients aged equal to or greater than 50 years, Patients with an increased risk for cardiovascular disease. If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance. For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to baseline measurement. Stable Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs) for at least 6 weeks prior to baseline measurement. Subjects are not permitted any alcohol or caffeine-containing food or drinks from 12 hrs prior to study visits until discharge. In addition, no strenuous exercise is permitted for 24 hrs before the study visits.



Healthy controls

Healthy controls must meet the following criteria for study entry: Healthy subjects aged older than 50 years.

Subjects may not enter this study if they meet the following criteria: Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (within 1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy. Use medication for diabetes mellitus, or an elevated blood pressure. Are known with a BMI above 28. Recent or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including but not limited to: Steroids for at least 6 weeks prior to baseline measurement and during study (with the exception of inhaled steroids).
Biological based medicines (anti-TNF (ex. Infliximab), anti-IL-6 therapy (ex.
Tocilizumab) or anti-IL-1 (ex. anakinra)) within 8 weeks before the baseline visit and
during the study No other Disease modifying antirheumatic drugs (DMRADS) within 6 weeks of baseline and during study (such as cyclosporine, azatioprine, etc.) Any clinically significant medical condition that could interfere with the conduct of the
study. Standard contra-indications to MRI, 18FDG PET, and CT. Impaired hepatic function. Impaired renal function. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study. Subject has planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period or for 14 days after the last treatment.