Atherosclerosis vaatverkalking
Conditions
Interventions
Two weekly IV infusions of 150 mg Nanocort (PEG-liposomal prednisolone sodium phosphate).
or a placebo (Saline solution
same solution brand as used to dilute/prepare Nanocort injection).
Sponsors
Dept of vascular medicine, Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1. Male patients aged equal to or greater than (≥) 60 years; 2. Evidence of qualifying vessel (carotid or aortic) plaque inflammation defined as Target (Plaque) to Background (Blood) ratio (TBR) > 2.2, (calculated using the mean of the maximum SUV) as measured by 18FDG PET/CT; 3. Known with an elevated risk factor for cardiovascular disease for example, but not limited to: A. Body Mass Index > 26; B. Elevated blood pressure (> 135/85); C. Central obesity (according to “New International Diabetes Federation definition”); D. Reduced High density lipoprotein (HDL<1.03 mmol/L). 4. If using a statin, on stable therapy for at least 6 weeks prior to screening with no evidence of statin intolerance; 5. 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; 6. Stable Nonsteroidal anti-inflammatory drugs (NSAIDS), Cyclo-oxygenase-2 inhibitors (COXIBs) for at least 6 weeks prior to baseline measurement; 7. Subject agrees to the restrictions as described in paragraph 4.6. In brief: 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.
Exclusion criteria
Exclusion criteria: Subjects may not enter this study if they meet the following criteria: 1. Current medical history of Auto-immune disease/vasculitis, active inflammatory diseases, proven or suspected bacterial infections. Recent (7.5%; 6. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses; 7. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study; 8. 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; 9. Current medical history of drug or alcohol abuse within 12 months prior to screening; 10. Subjects are not permitted to enter the study if they have taken any investigational drug in the 3 months prior to study drug administration; 11. Subjects are not permitted to enter the study if they have taken insulin or any oral anti-diabetic (except metformin) in the last 30 days. Those subjects who are taking metformin may be included in the study if they are on a stable dose for at least 4 weeks and have a HbA1c <7.5%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of short-term liposomal glucocorticoid (Nanocort) infusion on atherosclerotic plaque inflammation in humans measured by 18FDG PET/CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the effect of Nanocort infusion on plaque neovascularisation and endothelial permeability (DCE-MRI) of the carotid arteries and/or aorta; 2. To evaluate the effect of Nanocort infusion on inflammatory markers. | — |
Contacts
Public ContactErik Stroes
Department of Vascular Medicine, AMC
Outcome results
None listed