125
Participants
Start Date
December 6, 2022
Primary Completion Date
July 1, 2027
Study Completion Date
July 31, 2027
Evolocumab Cartridge
Injectable PCSK9 inhibitor.
Atorvastatin Calcium Tablets
HMG-CoA reductase inhibitor for oral use.
Ezetimibe Tablets
Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.
18F-FDG
Optional procedure. Positron emission tomography (PET) and computed tomography (CT) imaging to assess vascular inflammation and related anatomy requires injection of the PET tracer 18F-FDG. 18F-FDG is an FDA-approved analogue of sugar, routinely used to evaluate elevated metabolism in tissues, including increased metabolism due to inflammatory cells. A standard dose of 7.0 mSv will be administered.
Angiocatheter 20IV
Optional procedure (endothelial cell harvesting). An angiocatheter ≤ 21 gauge will be inserted into a peripheral vein on the upper extremity using aseptic technique. A 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be then advanced into the angiocatheter, to a distance of 4cm beyond the end of the angiocatheter.
J-Wire
Optional procedure (endothelial cell harvesting). Either a 0.021in. diameter J-shaped wire (Daig, Minnetonka, MN) or a 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be used.
GlycoCheck Glycocalyx Measurement Software
Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.
RECRUITING
New York VA Hospital, New York
RECRUITING
NYC Health + Hospitals/Bellevue, New York
RECRUITING
NYU Langone Health, New York
RECRUITING
Mount Sinai School of Medicine, New York
National Heart, Lung, and Blood Institute (NHLBI)
NIH
NYU Langone Health
OTHER