Assessment of Coronary Plaque Composition Using Optical Coherence Tomography During Chronic Inhibition of Lp-PLa2 Activity


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The present study will be 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 LpPLA2 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 month 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.

Who is eligible to participate?

Inclusion Criteria: - age > 18 years and < 85 years - referred to our cardiac catheterization laboratory for coronary vasomotion testing - are found to have coronary endothelial dysfunction. Exclusion Criteria: - these include heart failure - ejection fraction < 40% - unstable angina - myocardial infarction or angioplasty within 6 months prior to entry into the study - use of investigational agents within 1 month of entry into the study, - patients who require treatment with positive inotropic agents other than digoxin during the study - patients with cerebrovascular accident within 6 months prior to entry the study - significant endocrine, hepatic or renal, disorders - local or systemic infectious disease within 4 weeks prior to entry into study - pregnancy or lactation - mental instability - Federal Medical Center inmates

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