Endothelial Dysfunction Clinical Trial
Official title:
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.
The present study was a substudy of our National Institute of Health (NIH) funded and
Institutional Review Board (IRB) approved (08-008161) protocol "Lp-PLA2 and Coronary
Atherosclerosis in Humans" and (10-000044) "Lp-PLA2 and Coronary Atherosclerosis in Humans
Aim III" in which the investigators are examining the impact of long-term inhibition of
Lp-PLA2, with a specific novel inhibitor, on Lp-PLA2 activity and improvement in coronary
endothelial function.
This substudy will use Optical Coherence Tomography (OCT) to quantify alternate features of
plaque vulnerability including superficial microcalcification, fibrous cap thickness, and
plaque macrophage content at baseline and again at 6 months following Lp-PLA2 inhibition.
The study will provide insight into the role of the endogenous Lp-PLA2 in early coronary
atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in
humans.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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