Assessment of Coronary Plaque Composition Using Optical Coherence Tomography



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:October 2010
End Date:June 2015

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

The investigators 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 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.

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
We found this trial at
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Rochester, Minnesota 55905
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Rochester, MN
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