arteriosclerosis atherosclerosis
Conditions
Interventions
Two infusions with Nanocrt 150 mg or placebo
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Target population will consist of subjects with an increased risk for cardiovascular disease and severe inflamed carotid or aortic atherosclerosis plaques.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline to day 9-15 in TBR from an index vessel (carotid artery and aorta) as measured with 18FDG PET/CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in Ktrans on carotid artery and aorta as measured with DCE Changes in inflammatory markers as measured with routine methods | — |
Countries
Netherlands
Outcome results
None listed